Nghị định 176/2013/ND-CP

Decree No. 176/2013/ND-CP dated November 14, 2013, penalties for administrative violations against medical laws

Nội dung toàn văn Decree No. 176/2013/ND-CP penalties for administrative violations against medical laws


THE GOVERNMENT
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 176/2013/ND-CP

Hanoi, November 14, 2013

 

DECREE

PENALTIES FOR ADMINISTRATIVE VIOLATIONS AGAINST MEDICAL LAWS

Pursuant to the Law on Government organization dated December 25, 2001;

Pursuant to the Law on Penalties for administrative violations dated June 20, 2012;

Pursuant to the Law on Pharmacy dated June 14, 2005;

Pursuant to the Law on Prevention of HIV/AIDS dated June 29, 2006;

Pursuant to the Law on Donation, removal and transplantation of human tissues and organs, and body donation dated November 29, 2006;

Pursuant to the Law on Prevention of infectious diseases dated November 21, 2007;

Pursuant to the Law on Health insurance dated November 14, 2008;

Pursuant to the Law on Medical examination and treatment dated November 23, 2009;

Pursuant to the Law on Prevention of harmful effects of tobacco dated June 18, 2012;

Pursuant to the Ordinance on Population dated January 09, 2003 and the Ordinance dated December 27, 2008 on amendments to Article 10 of the Ordinance on Population;

At the request of the Minister of Health,

The government promulgates a Decree on penalties for administrative violations against medical laws.

Chapter 1.

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Decree deals with the administrative violations, penalties, fines, and remedial measures; the persons entitled to make violation records, impose penalties, and the maximum fines they can impose upon administrative violations against medical laws.

2. In this Decree, administrative violations against medical laws are wrongful acts committed by organizations and individuals that contravene medical laws but do not constitute criminal offenses and are punishable by administrative penalties, including:

a) Violations against regulations on defensive medicine and prevention of HIV/AIDS;

b) Violations against regulations on medical examination and treatment;

c) Violations against regulations on pharmacy, cosmetics, and medical equipment;

d) Violations against regulations on health insurance;

dd) Violations against regulations on population.

3. Other administrative violations that are not mentioned in this Decree shall incur the penalties prescribed by the Decrees in which they are mentioned.

Article 2. Subjects of application

1. Vietnamese entities and foreign entities that commit administrative violations against medical laws within Vietnam’s territory.

2. The persons entitled to make violation records, impose penalties, and relevant entities.

Article 3. Remedial measures

Apart from the remedial measures mentioned in Points a, c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on Penalties for administrative violations, the entities that commit administrative violations against medical laws might have to take one of the following remedial measures depending on the nature and severity of the violations:

1. Decontaminating, disinfecting wastes, clothing, equipment, the environment, and patient transport vehicles;

2. Admitting sufferers of group A diseases;

3. Treating and keeping the people, vehicles, and goods that carry pathogens of group A diseases in isolation;

4. Admitting HIV sufferers, admitting, burying or cremating the bodies of HIV sufferers;

5. Offering public apologies by means of mass communication;

6. Returning the illegal money to the account of the health insurance fund or the medical facility;

7. Returning the interest on late payment of health insurance premium to the account of the health insurance fund;

8. Returning the interest on the difference caused by incorrect declaration or the interest on deferred payment;

9. Returning the medical cost covered by health insurance that was paid by the policyholder. Such amount shall be transferred to government budget if the recipients are not identifiable;

10. Removing the instructions on sex selection;

11. Removing intrauterine devices or implanted contraceptives;

12. Requesting a competent authority to revoke communicator’s cards, identification numbers of cosmetic notification, health insurance cards, drug registration numbers.

Article 4. Fines incurred by individuals and organizations

1. The maximum fine for a violation pertaining to population incurred by an individual is 30,000,000 VND; That incurred by an organization is 60,000,000 VND.

2. The maximum fine for a violation pertaining to defensive medicine and HIV/AIDS prevention incurred by an individual is 50,000,000 VND; That incurred by an organization is 100,000,000 VND.

3. The maximum fine for a violation pertaining to health insurance incurred by an individual is 75,000,000 VND, that incurred by an organization is 150,000,000 VND.

4. The maximum fine for a violation pertaining to medical examination and treatment, pharmacy, cosmetics, or medical equipment incurred by an individual is 100,000,000 VND, that incurred by an organization is 200,000,000 VND.

5. The fines for the violations mentioned in Chapter II of this Decree are imposed upon individuals. The incurred by an organization is twice the fine incurred by the individual that commits the same violation.

6. The maximum fines the persons mentioned in Chapter III of this Decree may impose are applied to individuals. The maximum fines such persons may impose upon an organization is twice the maximum fines imposed on individuals.

Chapter 2.

VIOLATIONS, PENALTIES, AND REMEDIAL MEASURES

SECTION 1. VIOLATIONS PERTAINING TO DEFENSIVE MEDICINE AND PREVENTION OF HIV/AIDS

Article 5. Violations pertaining to education and propagation of information about prevention and treatment of infectious disease

1. Any establishment that fails to carry out annual propagation of information about prevention and treatment of infectious diseases among employees shall be liable to:

a) A warning or a fine of from 200,000 VND to 500,000 VND if the establishment has fewer than 50 employees;

b) A fine of from 500,000 VND to 1,000,000 VND if the establishment has 50 - 99 employees;

c) A fine of from 1,000,000 VND to 3,000,000 VND if the establishment has 100 - 299 employees;

d) A fine of from 3,000,000 VND to 5,000,000 VND if the establishment has 300 - 499 employees;

dd) A fine of from 5,000,000 VND to 10,000,000 VND if the establishment has 500 - 999 employees;

e) A fine of from 10,000,000 VND to 15,000,000 VND if the establishment has 1,000 - 1,499 employees;

g) A fine of from 15,000,000 VND to 20,000,000 VND if the establishment has 1,500 - 2,499 employees;

h) A fine of from 20,000,000 VND to 25,000,000 VND if the establishment has 2,500 employees or more;

2. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Provision of information about the development of the epidemic that is inconsistent with the information announced by competent health authorities;

b) Failure to properly provide information about prevention and treatment of infectious diseases in terms of time, duration, and location.

3. A fine of from 10,000,000 VND to 15,000,000 VND shall be imposed for making improper charges for provision of information about prevention and treatment of infectious diseases by means of mass communication, unless the contract to run a program is signed or the program is sponsored by a Vietnamese or foreign entity.

4. A fine of from 15,000,000 VND to 20,000,000 VND shall be imposed for taking advantage of propagation of information about prevention and treatment of infectious diseases to threaten the security, social order, or to breaks cultural traditions and social ethics.

5. Remedial measures:

a) Incorrect information must be rectified by means of mass communication for 03 consecutive days in event of the violations in Point a Clause 2 of this Article;

b) The illegal money mentioned in Clause 3 of this Article must be returned.

Article 6. Violations pertaining to monitoring infectious diseases

1. The failure to report sufferers of group A diseases shall be liable to a warning or a fine of from 200,000 VND to 500,000 VND.

2. One of the following violations shall be liable to a fine of from 500,000 VND to 1,000,000 VND:

a) Concealment of the development of group A diseases of oneself or of other people;

b) Failure to take the test for group A diseases at the request of a competent authority.

Article 7. Violations pertaining biosafety at laboratories

1. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Failure to ensuring biosafety after the Certificate of biosafety level 1 is obtained;

b) Running the tests beyond the Certificate of biosafety;

c) Failure to formulate and implement the Regulation on internal biosafety inspection;

d) Failure to comply with the procedures for testing, collecting, moving, preserving, keeping, using, studying, exchanging, or destroying pathology specimens related to the pathogens of infectious diseases group C;

dd) Failure to obtain qualifications suitable for the tests being run; failure of the supervisor and personnel of the biosafety level 1 laboratory (BSL-1 laboratory) to obtain certificates of training in biosafety.

2. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to ensuring biosafety after the Certificate of biosafety level 2 is obtained;

b) Failure to make a plan for preventing and responding to biosafety emergencies after the certificate of biosafety is obtained;

c) Failure to provide training in responses to biosafety emergencies for laboratory personnel;

d) Failure to provide personal protective equipment for personnel of biosafety laboratory;

dd) Failure to obtain qualifications suitable for the tests being run; failure of the supervisor and personnel of the BSL-2 laboratory to obtain certificates of training in biosafety level 2 or higher.

3. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Running tests for pathogens of group B and C diseases without a certificate of biosafety issued by a competent authority;

b) Failure to comply with the procedures for testing, collecting, moving, preserving, keeping, using, studying, exchanging, or destroying pathology specimens related to the pathogens of group B diseases;

c) Failure to obtain qualifications suitable for the tests being run; failure of the supervisor and personnel of the BSL-3 or BSL-4 laboratory to obtain certificates of training in biosafety level 3 or level 4 or higher.

4. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

b) Failure to ensure biosafety after obtaining a certificate of biosafety level 3 or level 4;

b) Running tests for pathogens of group A diseases without a certificate of biosafety issued by a competent authority;

c) Failure to comply with the procedures for testing, collecting, moving, preserving, keeping, using, studying, exchanging, or destroying pathology specimens related to the pathogens of group A diseases.

5. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Failure to practice responding to biosafety emergencies annually at the BSL-3 or BSL-4 laboratory;

b) Failure to report serious biosafety emergencies and the measures taken to Services of Health;

c) Running tests without an appropriate certificate of biosafety or using an expired certificate of biosafety.

6. Additional penalties:

a) Any entity that commits the violations in Point a Clause 1, Point a Clause 2, Point a Clause 3, Point a and Point b Clause 4 of this Article shall be suspended from testing for 01 to 03 months;

b) Any entity that commits the violations in Point dd Clause 1, Point dd Clause 2, Point b and Point c Clause 3, Point b and Point c Clause 4 of this Article shall have their practising certificate revoked for 01 to 03 months.

Article 8. Violations against regulations on using vaccines and biologicals

1. The failure to use or obstruction of the use of vaccines and biologicals against the infectious diseases in the open inoculation program shall be liable to a warning or a fine of from 200,000 VND to 500,000 VND.

2. The failure to use vaccines biologicals when living in or going to infected areas where the risk of catching infectious diseases is high shall be liable to a fine of from 500,000 VND to 1,000,000 VND.

3. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Failure to follow the procedures for receiving, transporting, preserving, and dispensing vaccines and biologicals;

b) Failure to follow the reporting practice or retain documents about the use of vaccines and biologicals as prescribed by law.

4. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Using vaccines and biologicals at an unsatisfactory facility;

b) Failure to follow the procedure for safe inoculation as prescribed by law;

c) Selling vaccines and biologicals of the open inoculation program.

5. A fine of from 30,000,000 VND to 40,000,000 VND shall be imposed for using expired vaccines or using vaccines without registration numbers.

6. Additional penalties:

Any entity that commits the violations in Point c Clause 4 and Clause 5 of this Article shall have their practising certificate revoked for 01 to 03 months.

7. Remedial measures:

a) Illegal profit earned from committing the violations in Point c Clause 4 of this Article must be returned;

b) The expired vaccines shall be destroyed in event of the violations in Clause 5 of this Article;

c) The vaccines without registration numbers shall be withdrawn in event of the violations if Clause 5 of this Article.

Article 9. Violations against regulations on prevention of transmission of infectious diseases at medical facilities

1. Any of the following violations shall carry a warning or fine of from 100,000 VND to 300,000 VND:

a) Failure to report or to truthfully report in a timely manner the development of infectious disease that one catches to responsible physicians or health workers;

b) Failure to follow the indications and instructions on how to prevent transmission of infectious diseases of the physicians, health workers, and regulations of the medical facility;

c) Failure to register for health monitoring at the medical station of the commune after the sufferer of a group A disease is discharged from the hospital.

2. Any of the following violations shall carry a fine of from 1,000,000 VND to 2,000,000 VND:

a) Failure to provide personal protective equipment and hygiene conditions for physicians, health workers, patients, and their families;

b) Failure to notify the local defensive medicine of information about the sufferers of infectious diseases being diagnosed and treated at one’s medical facility;

c) Failure to give patients and their families advices on prevention and treatment of infectious diseases;

d) Failure to monitor the health of the physicians and health workers that directly take care and treat the sufferers of group A diseases.

3. A fine of from 3,000,000 VND to 5,000,000 VND shall be imposed for the failure to decontaminate, disinfect wastes, clothing, equipment, the surrounding environment, and the vehicles used for transporting sufferers of group B and C diseases.

4. A fine of from 7,000,000 VND to 10,000,000 VND shall be imposed for the failure to decontaminate, disinfect wastes, clothing, equipment, the surrounding environment, and the vehicles used for transporting sufferers of group A diseases.

5. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) Refusal to admit sufferers of group A diseases to the medical facility;

b) Failure to take measures for preventing the transmission of group A diseases

6. Remedial measures:

Any entity that commits the violation in Point a Clause 5 of this Article shall be compelled to admit sufferers of group A diseases.

Article 10. Violations against regulations on isolation and enforced isolation

1. Any of the following violations shall carry a fine of from 2,000,000 VND to 5,000,000 VND:

a) Failure to apply isolation or enforced isolation where necessary as prescribed by law, except for the case in Point a Clause 2 of this Article;

b) Refusal or avoidance of isolation or enforced isolation by competent authorities, except for the case in Point b Clause 2 of this Article;

c) Failure to enumerate and monitor the health of the persons in contact with the persons kept in isolation as prescribed by law;

d) Applying isolation or enforced isolation at unsatisfactory places as prescribed by law.

2. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to keep sufferers of group A diseases in isolation;

b) Refusing to or avoiding keeping sufferers of group A diseases, the subjects in quarantine that carry group A diseases or pathogens of group A diseases.

3. Remedial measures:

Isolation shall be enforced in event of the violations in Point a and Point b Clause 1, Clause 2 of this Article.

Article 11. Violations against regulations on epidemic prevention

1. Any of the following violations shall carry a warning or fine of from 100,000 VND to 300,000 VND:

a) Failure to provide personal protective equipment for the participants in epidemic prevention and the people at risk of catching diseases according to instructions of health authorities;

b) Failure to notify the local People’s Committee and defensive medicine body of the cases of infection.

2. Any of the following violations shall carry a fine of from 1,000,000 VND to 2,000,000 VND:

a) Concealing the infection of oneself or of other people after the epidemic is announced;

b) Failure or refusal to carry out cleaning and disinfection in the infected area.

3. Any of the following violations shall carry a fine of from 2,000,000 VND to 5,000,000 VND:

a) Failure to participate in epidemic prevention at the request of Epidemic Prevention Council;

b) Making charges for diagnosis and treatment of group A diseases;

c) Failure to implement the decision on destruction of animals, plants, and other organisms that are vectors of pathogens, except for the case in Point c Clause 5 of this Article;

4. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to suspend the operation of public food and drink establishments at risk of spreading the disease in the infected area;

b) Failure to impose a ban on the foods that are vectors of pathogens;

c) Failure to take measures for preventing crowds or to suspend the businesses at public places.

5. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Failure to comply with decisions on inspection, supervision, and medical procedures before leaving or entering an area infected with a group A disease;

b) Bringing the items, animals, foods, and other goods at risk of spreading the disease out of an area infected with a group A disease;

c) Failure to implement the decision on compelled destruction of animals, plants, and other organisms that are vectors of group A diseases.

6. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) Failure to comply with the request for inspection and medical procedures of the vehicles before leaving the infected area that is in a state of emergency;

b) Failure to comply with the decision to ban gatherings in the area where a state of emergency over the epidemic is declared;

c) Taking unauthorized people or vehicles to the area where a state of emergency over the epidemic is declared;

d) Failure to comply with the decision to ban gatherings in the area where a state of emergency over the epidemic is declared;

7. Remedial measures:

a) Cleaning and disinfection must be carried out in the infected area in event of the violation mentioned in Point b Clause 2 of this Article;

b) The illegal money mentioned in Point b Clause 3 of this Article must be returned. Such amount shall be transferred to government budget if the recipients are not identifiable;

c) The animals, plants, and other organisms must be destroyed in event of the violation in Point c Clause 5 and Point d Clause 6 of this Article.

Article 12. Violations against regulations on bordering quarantine

1. Any of the following violations shall carry a fine of from 1,000,000 VND to 2,000,000 VND:

a) Failure to report bordering quarantine as prescribed;

b) Refusal to inspect the subjects in quarantine.

2. Any of the following violations shall carry a fine of from 2,000,000 VND to 5,000,000 VND:

b) Refusal to comply with instructions of quarantine officers;

b) Failure’s of the owner of inbound watercraft to signal the request of quarantine;

c) Failure to take measures for prevention of mice and other vectors on the vehicles when they are parking or anchoring at night or for more than 24 hours at the border checkpoint or quarantine post;

d) Failure to contact the quarantine office at the border checkpoint by radio before landing the airplane in case a passenger or crewmember on the flight is suspected of being infected.

3. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Falsifying the certificate of quarantine;

b) Transporting corpses, bones, bioproducts, bacteria, human organs, tissues, blood, and constituents of blood through the border checkpoint without undergoing an inspection and issued with a certificate of quarantine by the quarantine office;

c) Concealing the case that need keeping in quarantine.

4. Any of the following violations shall carry a fine of from 15,000,000 VND to 20,000,000 VND:

a) Failure to treat and keep the people, vehicles, and goods that carry pathogens of group A diseases in isolation or quarantine;

b) Fabricating the certificate of quarantine.

5. Remedial measures:

a) The people, vehicles, and goods that carry pathogens of group A diseases shall be treated, kept in isolation or quarantine in event of the violation in Point a Clause 4 of this Article;

b) The certificate of quarantine shall be destroyed in event of the violation in Point a Clause 3 and Point b Clause 4 of this Article.

Article 13. Violations against regulations on defensive medicine

A fine of from 500,000 VND to 1,000,000 VND shall be imposed for employing sufferers to do the jobs that threaten to spread infectious diseases.

Article 14. Violations against regulations on water and air hygiene

1. A warning or a fine of 200,000 VND to 500,000 VND shall be imposed for dumping less than 1m3 of rubbish, excreta of human and animals per 24 hours to water sources used for household purposes or to public places.

2. A fine of 1,000,000 VND to 2,000,000 VND shall be imposed for dumping ≥ 1 m3 of rubbish, excreta of human and animals per 24 hours to water sources used for household purposes or to public places.

3. Any entity that provides less than 1,000 m3 of water per 24 hours serving household purposes or to public places shall get a fine of from 5,000,000 VND to 10,000,000 VND for any of the following violations:

a) Failure to adhere to eh regulations on inspecting and monitoring the water quality according to national standards of quality of water for household purposes;

b) Provision of water for household purposes that fails to meet national standards of quality of water for household purposes.

4. Any entity that provides ≥ 1,000 m3 of water per 24 hours serving household purposes or to public places shall get a fine of from 5,000,000 VND to 10,000,000 VND for committing any of the violations in Point a and Point b Clause 3 of this Article.

5. Remedial measures:

Environmental pollution must be controlled in case of the violations mentioned in Clause 1 and Clause 2 of this Article.

Article 15. Violations against regulations on burial and cremation

1. Any of the following violations shall carry a warning or fine of from 200,000 VND to 500,000 VND:

a) Failure to adhere to the hygiene regulations when handling, transporting, embalming dead bodies, except for the cases in Point a and Point b Clause 3 of this Article;

b) Failure to use personal protective equipment during the burial or cremation;

c) Failure to keep a record of the information related to the funerals at the funeral parlor or crematory.

2. Any of the following violations shall carry a fine of from 2,000,000 VND to 5,000,000 VND:

a) Failure to ensure hygiene conditions at the funeral parlor or crematory;

b) Violations against regulations on delay of reinterment.

3. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to adhere to the hygiene regulations when handling, transporting, embalming dead bodies of sufferers of group A diseases and some of group B diseases in the list of infectious diseases that require isolation.

b) Failure to properly prepare dead bodies of the sufferers of group A diseases and some of group B diseases in the list of infectious diseases that require isolation;

c) Failure to adhere to the laws on mass burial.

4. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Failure to comply with regulations on preparing dead bodies, bones, and the surroundings when moving a cemetery before appropriate time for reinterment;

b) Using land that was a cemetery without environmental impact assessment and environment sanitation suitable for the level of pollution, except for the case in Point a Clause 5 of this Article.

5. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) Using land that was a cemetery for one of the following purposes: extracting underground water serving household purposes; building public works such as resort, amusement park, kindergarten, school, sanitarium without environmental impact assessment and environment sanitation suitable for the level of pollution;

b) Using illegal cremation technologies.

6. Remedial measures:

Environmental pollution must be controlled in event of the violations mentioned in Clause 5 of this Article.

Article 16. Violations against regulations on medical setting

1. A fine of from 500,000 VND to 1,000,000 VND shall be imposed for dumping the substances and items that threaten to spread the infectious diseases and cause an epidemic to break out.

2. A fine of from 1,000,000 VND to 3,000,000 VND shall be imposed for failure to build satisfactory bathrooms at the office, medical facility, school, or other public establishments.

3. A fine of from 20,000,000 VND to 30,000,000 VND shall be imposed for building a industrial park, urban area, residential area, medical facility without assessment of impact on health.

Article 17. Violations against regulations on dissemination of information about HIV/AIDS prevention

1. Any establishment that fails to carry out annual dissemination of information about HIV/AIDS prevention among employees shall be given:

a) A warning or a fine of from 200,000 VND to 500,000 VND if the establishment has fewer than 50 employees;

b) A fine of from 500,000 VND to 1,000,000 VND if the establishment has 50 - 99 employees;

c) A fine of from 1,000,000 VND to 2,000,000 VND if the establishment has 100 - 199 employees;

d) A fine of from 2,000,000 VND to 5,000,000 VND if the establishment has 200 - 499 employees;

dd) A fine of from 5,000,000 VND to 10,000,000 VND if the establishment has 500 - 999 employees;

e) A fine of from 10,000,000 VND to 15,000,000 VND if the establishment has 1,000 - 1,499 employees;

g) A fine of from 15,000,000 VND to 20,000,000 VND if the establishment has 1,500 - 1,999 employees;

h) A fine of from 20,000,000 VND to 25,000,000 VND if the establishment has 2,000 - 2,499 employees;

i) A fine of from 25,000,000 VND to 30,000,000 VND if the establishment has 2,500 employees or more.

2. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Provision of different information about the development of HIV/AIDS pandemic from that announced by competent authorities;

b) Obstruction of dissemination of information about HIV/AIDS prevention;

c) Refusal to cooperate with local HIV/AIDS prevention body in disseminating information about HIV/AIDS prevention;

d) Failure to strictly adhere to the laws on posting information about HIV/AIDS prevention in terms of time, duration, and locations.

3. Any of the following violations shall carry a fine of from 10,000,000 VND to 15,000,000 VND:

a) Failure to adhere to the law on posting information about HIV/AIDS prevention in terms of time, duration, and locations;

b) Making charges for HIV/AIDS prevention programs by means of mass communication, unless a contract is signed with the national HIV/AIDS prevention program, or the program is sponsored by a Vietnamese or foreign entity;

c) Revealing that a person is infected with HIV without the person’s consent, unless such information is provided to serve the HIV/AIDS epidemiological surveillance or when a HIV test result is given;

d) Taking advantage of propagation of information about HIV/AIDS prevention to threaten the security, social order, or to breaks cultural traditions and social ethics.

4. Any of the following violations shall carry a fine of from 15,000,000 VND to 20,000,000 VND:

a) Fabricating information about a healthy person’s being infected with HIV;

b) Publicizing the name, address, or picture of an HIV sufferer without the person’s consent, unless such information is provided to serve the HIV/AIDS epidemiological surveillance or when a HIV test result is given;

c) Using pictures or messages that discriminate against HIV sufferers and their families for propagation.

5. Remedial measures:

a) Incorrect information must be rectified by means of mass communication for 03 consecutive days in event of the violations in Point a Clause 2 of this Article;

b) The illegal money mentioned in Point b Clause 3 of this Article must be returned. Such amount shall be transferred to government budget if the recipients are not identifiable;

c) The HIV sufferers and their families must be offered apologies by means of mass communication for 03 days in event of the violations mentioned in Point c Clause 3 and Point c Clause 4 of this Article, unless public apologies are not accepted by the HIV sufferers;

d) The HIV sufferers and their families must be offered apologies by means of mass communication for 03 days in event of the violations mentioned in Point c Clause 3 and Point c Clause 4 of this Article, unless public apologies are not accepted by the HIV sufferers;

Article 18. Violations against regulations on HIV testing and counseling

1. Any of the following violations shall carry a fine of from 1,000,000 VND to 3,000,000 VND:

a) Obstruction of the right to access HIV/AIDS prevention counseling services;

b) Failure to provide counseling on HIV/AIDS prevention while tending or treating pregnant or breast-feeding HIV sufferers, or the people exposed to HIV;

c) Failure to follow the counseling procedure before and after the HIV testing;

d) Providing counseling on HIV/AIDS prevention at an unsatisfactory facility;

dd) Violations against regulations on reporting back the list of HIV sufferers during HIV/AIDS surveillance as prescribed by law;

e) Violations against regulations on retention of test results, retention and destruction of blood samples, blood bags, blood products, and HIV specimens;

g) Violations against regulations on HIV/AIDS reporting.

2. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Failure to provide counseling before and after the HIV testing;

b) Violations against regulations on the time to notify positive HIV test result;

c) Violations against regulations on the procedure for notifying positive HIV test result;

d) Violations against regulations on transport and delivery of notifications of positive HIV test result;

dd) Collecting money from the people required to test for HIV when a background check is requested or under a decision of an investigation body, the People’s Procuracy, or People’s Court, or pregnant women that voluntarily test for HIV when the testing cost is covered by another source.

e) Refusal to provide legal assistance for HIV sufferers as prescribed by law.

3. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Confirming HIV test results using the methods that are not accredited by law;

b) Notifying positive HIV test result to the patient without permission;

c) Requesting any person under 16 years of age or incapable of civil acts to test for HIV without written consent of their parents or guardians, unless emergency treatment is needed.

4. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Compelling the people beyond the HIV/AIDS epidemiological surveillance program or those that are not required to test for HIV to test for HIV as prescribed by law;

b) Testing for HIV using expired diagnostic reagents or those that have not been licensed.

5. Additional penalties:

The practising certificate shall be suspended for 01 - 03 months in event of the violations mentioned in Point b Clause 4 of this Article.

6. Remedial measures:

a) The illegal money mentioned in Point dd Clause 2 of this Article must be returned. Such amounts shall be transferred to government budget if the recipients are not identifiable;

b) The expired diagnostic reagents mentioned in Point b Clause 4 of this Article must be destroyed.

Article 19. Violations against regulations on treating and caring for HIV sufferers

1. A fine of from 1,000,000 VND to 2,000,000 VND shall be imposed for prescribing antiretroviral drugs without a certificate of training in HIV/AIDS treatment.

2. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Treating with antiretroviral drugs at an unsatisfactory facility;

b) Failure to comply with the laws on priority of access to antiretroviral drugs;

c) Failure to monitor, provide care and counseling for HIV sufferers at rehabilitation centers;

d) Failure to provide instructions on taking precautions against transmission of HIV for the people exposed to HIV.

3. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to monitor and provide treatment for pregnant HIV sufferers under one’s management;

b) Failure to take precautions against transmission of HIV from the people exposed to HIV;

c) Obstructing HIV sufferers from caring for other HIV sufferers, or from healthcare and treatment services;

d) Failure to provide adequate health care for HIV sufferers at social protection centers;

dd) Charging for the medicines and treatment that have been covered by another source.

4. Any of the following violations shall carry a fine of from 10,000,000 VND to 15,000,000 VND:

a) Refusal to treat HIV sufferers with antiretroviral drugs while they are eligible for treatment;

b) Using the methods that have not been permitted by competent authorities to treat HIV/AIDS.

5. Remedial measures:

The illegal money mentioned in Point dd Clause 3 of this Article must be returned. Such amount shall be transferred to government budget if the recipients are not identifiable.

Article 20. Violations against regulations on harm reduction in preventing the transmission of HIV

1. A warning or a fine of from 50,000 VND to 100,000 VND shall be given to any communicator that commits one of the following violations:

a) Failure to wear the communicator’s card while practicing harm reduction;

b) Using expired communicator’s card while practicing harm reduction, unless it is permitted by the issuer pending the issuance of the new one;

c) Falsifying or lending the communicator’s card.

2. Any of the following violations shall carry a fine of from 500,000 VND to 1,000,000 VND:

a) Failure to announce the harm reduction in prevention of HIV transmission organized by the People’s Committee and the police department of the commune;

b) Failure to present and transfer a photocopy of the medical records of the patients treated with antiretroviral drugs to the new facility, which is more convenient to them;

c) Failure to receive valid medical records of the patients treated with antiretroviral drugs sent by another facility;

b) Termination of substitution treatment for opioid dependence, unless otherwise permitted by law.

3. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Using the communicator’s card for improper purposes or beyond the scope of the harm reduction program;

b) Failure to cooperate with a local HIV/AIDS prevention body in harm reduction in prevention of HIV transmission;

c) Failure to follow the procedure for selecting opioid addicts being treated;

d) Stop following the regimen of substitution treatment for opioid dependence as prescribed by law;

dd) Failure to keep treating the patients sent by other facilities who have been treated with antiretroviral drugs;

e) Accommodation establishments failing to provide condoms.

4. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Giving substitution treatment for opioid dependence without appointment or certificates of training in substitution treatment for opioid dependence;

b) Selling condoms and needles that are supposed to be provided free of charge according to law, or selling subsidized condoms and needles at higher prices;

c) Obstruction of harm reduction in prevention of HIV transmission;

d) Failure to suspend and revoke the communicator’s card when its holder is found committing the violations that lead to the suspension and revocation of the card;

d) Providing substitution treatment for opioid dependence for ineligible people or at unsatisfactory facilities as prescribed by law;

e) Forcing the people addicted to opioids to treat their addiction in any shape or form.

5. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) Selling opioid substitutes that are supposed to be provided free of charge, or providing such substitutes for the facilities that are not permitted to treat opioid addiction.

b) Providing substitution treatment for opioid dependence without adequate conditions or without a operating license;

c) Failure to print the text “Provided free of charge. Not for sale” on the package or label of the condoms, needles that belong to the harm reduction program;

d) Taking advantage of substitution treatment for opioid dependence to illegally use or allowing other people to illegally use narcotics.

6. Additional penalties:

a) The communicator’s card shall be revoked in event of the violation mentioned in Point c Clause 1 of this Article;

b) The practising certificate shall be suspended for 01 - 03 months in event of the violations mentioned in Point d Clause 3 and Point a Clause 4 of this Article;

c) Substitute drugs shall be confiscated in event of the violation mentioned in Point a Clause 5 of this Article.

7. Remedial measures:

Illegal profit earned from violations mentioned in Point a Clause 5 of this Article must be returned.

Article 21. Discrimination against HIV sufferers

1. Any of the following violations shall carry a warning or fine of from 100,000 VND to 300,000 VND:

a) Obstructing the admission of a student to an educational institution that belongs to the national education system because that student or a member of their family is infected with HIV;

b) Obstructing a student from participating in the activities or service provision of an educational institution that belongs to the national education system because that student or a member of their family is infected with HIV;

c) Obstructing the admission of an eligible person to a social protection center because that person is infected with HIV;

d) Refusal to bury or cremate the people that die of HIV/AIDS.

2. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Refusal to employ the people that are infected with HIV or suspected to be infected with HIV, except for the jobs that require a test for HIV before employment;

b) Refusal to admit a student to the educational institutions that belong to the national education system because that student or a member of their family is infected with HIV;

c) Refusal to admit an eligible person to a social protection center because that person is infected with HIV;

d) Parents abandoning HIV-infected underage children; guardians abandoning HIV-infected wards;

dd) Isolating, prohibiting a student from participating in the activities or service provision of an educational institution that belongs to the national education system because that student or a member of their family is infected with HIV;

e) Discrimination while providing treatment for HIV sufferers;

g) Failure to assign appropriate jobs for HIV-infected workers as prescribed by law.

3. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Terminating labor contracts or obstructing the works of HIV-infected workers;

b) Forcing HIV-infected workers to change their job while they still have enough health;

c) Refusing to raise the wage, promote, or provide lawful benefits for HIV-infected workers.

d) Disciplining or expelling a student because that student, a member, or their family is infected with HIV.

4. Remedial measures:

a) The bodies and bones of HIV sufferers must be received, buried or cremated in event of the violations mentioned in Point d Clause 1 of this Article;

b) The HIV sufferer must be admitted in event of the violations mentioned in Points a, b, c, and d Clause 2 of this Article;

c) The person discriminated against must be offered apologies in event of the violation mentioned in Point e Clause 2 of this Article;

d) The HIV-infected workers must get back their old job in event of the violations mentioned in Point b Clause 3 of this Article.

Article 22. Violations against other regulations on HIV/AIDS prevention

1. Any of the following violations shall carry a fine of from 2,000,000 VND to 5,000,000 VND:

a) Requesting workers to test for HIV or to present HIV test results, except for the jobs that require a test for HIV before employment;

b) Requesting students to test for HIV or to present HIV test result when they apply to the school.

2. A fine of from 5,000,000 VND to 10,000,000 VND shall be imposed for violations against the regulations on blood transfusion, sterilization, disinfection, or other regulations on prevention of HIV infection.

3. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Threatening to transmit HIV to other people;

b) taking advantage of HIV/AIDS prevention activities for self-seeking purposes or committing illegal acts.

Article 23. Violations against regulations on smoke-free areas

1. Any of the following violations shall carry a warning or fine of from 100,000 VND to 300,000 VND:

a) Smoking in smoke-free areas. Smoking on the plane shall carry the penalties prescribed by the regulations on civil aviation;

b) Discarding cigarette ash or filters improperly in smoking areas.

2. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Failure to put up “No smoking” signs in smoke-free areas;

b) Failure to request smokers to stop smoking in one’s establishment;

c) Failure to provide instructions and inspect the adherence to the smoking ban in the areas under one’s management.

3. A fine of from 5,000,000 VND to 10,000,000 VND shall be imposed for any of the following violations in designated smoking areas:

a) Failure to provide a ventilation system separated from the smoke-free area;

b) Failure to provide ashtrays;

c) Failure to put up the signs at noticeable positions;

d) Failure to have fire safety equipment;

Article 24. Violations against regulations on selling tobacco

1. A warning or a fine of from 100,000 VND to 300,000 VND shall be imposed for using tobacco before the age of 18.

2. Any of the following violations shall carry a fine of from 1,000,000 VND to 2,000,000 VND:

e) Displaying more than one pack or box of a tobacco brand;

b) Selling tobacco without labels or without health warnings printed on the package.

3. Remedial measures:

The tobacco without labels or health warnings shall be confiscated in event of the violation mentioned in Point b Clause 2 of this Article.

Article 25. Violations against regulations on labeling or printing health warnings on the tobacco packages

1. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) The design, position, area, or color of the health warnings is not conformable with law;

b) Failure to specify the number of cigarettes in the pack or the weight of other forms of tobacco;

c) Using words and phrases that mislead users into believing that tobacco only causes little harms, or cause users to misunderstand the harms of tobacco and tobacco smoke to human health.

2. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Producing or importing tobacco without labeling or printing health warnings on the packages;

b) Producing foreign brands of tobacco for sale at home without permission of competent authorities.

3. Additional penalties:

a) The license to produce, trade, or import tobacco shall be suspended for 03 - 06 months in event of the violations mentioned in Clause 1 of this Article;

b) All illegal items shall be confiscated in event of the violations mentioned in Clause 2 of this Article.

Article 26. Violations against regulations on smoking cessation

1. A warning or a fine of from 100,000 VND to 300,000 VND shall be given to any smoking cessation counselor that uses tobacco.

2. Any of the following violations shall carry a fine of from 1,000,000 VND to 2,000,000 VND:

a) Illegal establishment of a smoking cessation-counseling center or smoking cessation center;

b) Failure to have a separate room for direct smoking cessation counseling;

c) Failure to have documents about smoking cessation.

b) Failure to have a telephone, Internet, or other means of communication serving indirect smoking cessation counseling;

dd) Failure to notify the local Services of Health before providing smoking cessation services or counseling.

Article 27. Violations against other regulations on prevention of harmful effects of tobacco

1. A fine of from 500,000 VND to 1,000,000 VND shall be imposed for encouraging other people to use tobacco.

2. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Using pictures of tobacco on the publications for children;

b) Forcing other people to use tobacco;

c) Failure to include the prevention of harmful effects of tobacco in annual operating plan; failure to include the ban on smoking in workplaces in the internal rules.

3. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) Using tobacco names, brands, or symbols on other products/services;

b) Advertising tobacco directly to consumers in any shape or form;

c) Making the mandatory contribution behind schedule;

d) Incorrect declaration that leads to insufficient contribution.

4. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Sponsoring in any shape or form, except for the cases permitted by law.

b) Avoiding making the mandatory contribution.

5. Remedial measures:

a) The products shall be confiscated in event of the violation mentioned in Point a Clause 3 of this Article;

b) The difference due to overstatement must be returned in event of the violations in Point c and Point d Clause 3 of this Article;

c) The contribution arrears must be paid in event of the violations in Point b Clause 4 of this Article.

SECTION 2. VIOLATIONS AGAINST REGULATIONS ON MEDICAL EXAMINATION AND TREATMENT

Article 28. Violations against regulations on medical practicing and using practising certificates

1. Any of the following violations shall carry a warning or fine of from 200,000 VND to 500,000 VND:

a) Using alcohol or tobacco while giving examination or treatment;

b) Failure to wear name tags;

c) Failure to wear personal protective equipment.

2. A warning or a fine of from 1,000,000 VND to 3,000,000 VND shall be imposed for disrespect for patients’ rights as prescribed by law.

3. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Refusal to admit patients that are put on compulsory treatment orders;

b) Self-seeking provision of a medical service or self-seeking suggestion that the patient should go to another medical facility0}

c) Taking advantage of one’s job to sexually harass the patient;

d) Any foreigner that directly give medical examination and treatment in Vietnamese without being recognized as proficient in Vietnamese, or in a language other than Vietnamese without registration;

dd) Prescribing medicines in a language other than Vietnamese without registration, or the translator is not recognized as proficient in Vietnamese.

e) Falsifying the medical records;

g) Using superstitious methods when practicing medicines.

4. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) Selling drugs to patients in any shape or form, except for traditional medicine practitioners;

b) Giving or taking bribes during medical examination and treatment but below the level that constitutes a criminal offence.

5. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Practicing without a practising certificate;

b) Practicing while the practising certificate is revoked or suspended;

c) Practicing beyond the licensed scope, except for emergency treatment;

d) Practicing using a borrowed or rented practising certificate;

dd) Renting or lending the practising certificate to another person;

e) Failure to provide emergency treatment; refusal to examine or treat patients, except for the cases permitted by law.

6. Expulsion

Any foreigner that recommits one of the violations in Point a and Point b Clause 5 of this Article shall be expelled from Vietnam.

7. Additional penalties:

a) The practising certificate shall be suspended for 06 - 12 months in event of the violations mentioned in Clause 4, Point c and Point dd Clause 5 of this Article;

b) The practising certificate shall be suspended for 03 - 06 months in event of the violations mentioned in Point a and Point b Clause 5 of this Article.

8. Remedial measures:

The patient must be offered apologies in event of the violation in Point c Clause 3 of this Article.

Article 29. Violations against regulations on operating conditions and the use of the operating license of the medical facility

1. Any of the following violations shall carry a fine of from 1,000,000 VND to 2,000,000 VND:

a) Operating without a signboard or using a signboard that is not consistent with the operating license;

b) Failure to announce the practitioner’s name, working time, or charges.

2. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Failure to notify the licensing authority of the replacement of the person in charge of expertise of the facility;

b) Failure to notify the licensing authority of the replacement of a foreign practitioner.

c) Collecting higher charges for the medical examination and treatment services higher than the posted ones;

d) Failure to ensure adequate infrastructure, equipment or personnel during the operation.

3. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Refusal to admit patients that are put on compulsory treatment orders; deliberate provision of compulsory treatment for the individuals that are not put on compulsory treatment orders;

b) Failure to process medical wastes at the medical facilities other than hospitals and general clinics;

c) Operating at a place other than that written in the license.

4. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) Failure to ensure necessary conditions for medical examination and treatment within the licensed scope;

b) Employing the practitioners that do not have practising certificates or that have their practising certificates suspended or revoked;

c) Failure to treat medical wastes at hospitals and general clinics.

5. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Using a borrowed or rented operating license;

b) Lending or renting the operating license;

6. Any of the following violations shall carry a fine of from 50,000,000 VND to 70,000,000 VND:

a) Providing medical examination and treatment services without operating license or while the operation is suspended;

b) Providing medical examination and treatment services beyond the scope in the operating license, except for emergency treatment;

c) Experimenting or applying new methods for medical examination and treatment without the approval of the Minister of Health or the Director of the Service of Health.

7. Additional penalties:

a) The operating license shall be suspended for 03 - 06 months in event of the violations mentioned in  Point c Clause 3, Point b Clause 4, Point b Clause 5, Point b and Point c Clause 6 of this Article;

b) The operation shall be suspended for 06 - 12 months in event of the violation mentioned in Point a Clause 6 of this Article.

8. Remedial measures:

The difference mentioned in Point c Clause 2 of this Article must be returned. Such amounts shall be transferred to government budget if the recipients are not identifiable.

Article 30. Violations against regulations on expertise

1. Any of the following violations shall carry a warning or fine of from 200,000 VND to 500,000 VND:

a) Failure to keep medical records or keeping insufficient medical records as prescribed by law;

b) Failure to keep medical records or keeping insufficient medical records as prescribed by law;

c) Failure to keep a log of outpatients;

d) Failure to retain medical records as prescribed by law,

2. Any of the following violations shall carry a fine of from 2,000,000 VND to 5,000,000 VND:

a) Abandoning patients without relatives as prescribed by law;

b) Abandoning dead patients;

c) Failure to provide medical examination and treatment as prescribed by law.

3. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to hold a consultation when the sickness is beyond the competence of the practitioner or the facility;

b) Failure to hold a degree when the sickness worsens does not respond well to treatment;

c) Failure to take measures for controlling bacterial contamination in the medical facility.

4. A fine of from 10,000,000 VND to 15,000,000 VND shall be imposed on any medical facility that fails to move the patient to another facility when the patient’s condition is beyond their competence.

5. Any of the following violations shall carry a fine of from 15,000,000 VND to 20,000,000 VND:

a) Performing a surgery or surgical intervention without the consent of the patient of their representative, unless the opinions of the patient or their representative cannot be obtained, or the patient’s life is threatened if the surgery or surgical intervention is not performed;

b) Failure to ensure the adequate quantity and quality of ambulances, medical equipment and medicines for emergency aid.

6. A fine of from 30,000,000 VND to 40,000,000 VND shall be imposed for any violation against regulations on expertise during medical examination and treatment that results in medical complications.

7. Additional penalties:

The practising certificate shall be suspended for 03 - 06 months in event of the violations mentioned in Clause 6 of this Article.

Article 31. Violations against regulations on using drugs at in-patients facilities

1. Any of the following violations shall carry a fine of from 1,000,000 VND to 2,000,000 VND:

a) Giving a prescription without sufficient, clear or accurate information about the names, quantity, concentrations, dosages, administration routes of drugs, and the drug use duration;

b) Failure to check the prescriptions, concentrations, administration routes, names, quantity, and quality of drugs; failure to compare the prescription with information about the concentration, quantity, and expiration dates when drugs are given to patients or the person appointed to dispense drugs;

c) Failure to check patient’s name, names, dosage forms, concentrations, dosage, administration routes of drugs and drug use duration before having the patient to use them;

d) Failure to keep a log of the drug dispensing time;

dd) Failure to keep a log of the clinical developments after the patient starts to use drugs;

e) Failure to identify and report complications after drugs are used to the responsible for practitioner.

2. A fine of from 5,000,000 VND to 10,000,000 VND shall be imposed for the failure to monitor the effects of drugs and to deal with complications caused by drugs of one’s patients.

3. A fine of from 10,000,000 VND to 20,000,000 VND shall be imposed for self-seeking prescription of expensive proprietary medicines.

4. A fine of from 40,000,000 VND to 50,000,000 VND shall be imposed on the use of unlicensed drugs for medical examination and treatment, unless the patient voluntarily participates in the clinical trial.

5. Additional penalties:

The practising certificate shall be suspended for 03 - 06 months in event of the violations mentioned in Clause 4 of this Article.

Article 32. Violations against regulations on massage services

1. Any of the following violations shall carry a warning or fine of from 200,000 VND to 500,000 VND:

a) Failure to put up or to properly put up the massage procedure in massage rooms;

b) Failure to wear proper outfits and badges when giving massages;

c) Giving massages without a certificate issued by a competent authority.

2. Any of the following violations shall carry a fine of from 2,000,000 VND to 5,000,000 VND:

a) Failure to have satisfactory massage beds;

b) Failure to install emergency bells in massage rooms;

c) Failure to ensure sufficient lighting and cleanliness as prescribed by law;

d) Failure to have massage rooms with sufficient areas as prescribed by law;

dd) Failure to have a cabinet of emergency drugs; the drugs in the cabinet are not sufficient or expired.

3. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to install satisfactory doors in massage rooms;

b) Taking advantage of the provision of massage services to provide prostitution.

Article 33. Violations against regulations on childbirth assistance

1. A fine of from 5,000,000 VND to 10,000,000 VND shall be imposed for revelation of the names, ages, addresses, or pictures of the donors and recipients of sperms or embryos.

2. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Donating/receiving eggs, sperms, or embryos without permission;

b) Failure to ensure sufficient conditions for childbirth assistance as prescribed by law.

3. Any of the following violations shall carry a fine of from 60,000,000 VND to 80,000,000 VND:

a) Carrying out surrogacy;

b) Carrying out cloning;

c) Transplanting sperms, eggs, or embryos among blood relatives or among people within three degrees of consanguinity.

4. Additional penalties:

The operation shall be suspended for 06 - 12 months in event of the violations mentioned in Clause 2 and Clause 3 of this Article.

Article 34. Violations against regulations on donation, removal and transplantation of human tissues and organs, and body donation

1. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Brokering the trading of human organs;

b) Revealing information about the donor and the recipient, unless otherwise agreed by both parties or prescribed by law;

c) Taking non-regenerable organs from a living human without written opinions from the organ donation council.

2. Any of the following violations shall carry a fine of from 60,000,000 VND to 80,000,000 VND:

a) Taking, transplanting, using, keeping human tissues or organs for commercial purposes;

b) Taking, transplanting human tissues or organs without being recognized by a competent authority as eligible for tissue or organ transplantation.

3. Any of the following violations shall carry a fine of from 80,000,000 VND to 100,000,000 VND:

a) Forcing other people to donate their tissues or organs; taking a person’s tissues or organs against his will;

b) Taking tissues or organs from a person under 18 years of age;

c) Transplanting tissues or organs of a person that suffers from one of the diseases in the list complied by a competent authority.

4. Additional penalties:

The operating license shall be suspended for 03 - 06 months in event of the violations mentioned in Point b Clause 2, Point b and Point c Clause 3 of this Article.

Article 35. Violations against regulations on sex reassignment

1. Any of the following violations shall carry a fine of from 2,000,000 VND to 5,000,000 VND:

a) Revelation of information about a person’s sex reassignment;

b) Discrimination against the people that have their sex reassigned.

2. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Performing sex reassignment on the individuals without gender identity disorder;

b) Performing sex reassignment surgery without the permission of the Minister of Health or the Director of the Service of Health.

3. Remedial measures:

The person discriminated against must be offer apologies in event of the violation mentioned in Point b Clause 1 of this Article.

Article 36. Violations against other regulations on medical examination and treatment

1. Any of the following violations shall carry a warning or fine of from 200,000 VND to 500,000 VND:

a) Failure to cooperate with the practitioners and the medical facility during medical examination and treatment;

b) Failure to comply with the practitioners’ orders, except for the case in which the patient is entitled to refuse treatment;

c) Failure to comply with the rules and regulations of the medical facility.

2. Any of the following violations shall carry a fine of from 1,000,000 VND to 2,000,000 VND:

a) Insulting the practitioners during medical examination and treatment;

b) Failure to comply with the mobilization of competent authorities in event of a natural disaster, calamity, or epidemic.

3. Any of the following violations shall carry a fine of from 2,000,000 VND to 5,000,000 VND:

a) Failure to pay the medical cost, unless they are exempt or reduced by law;

b) Failure to establish an expertise council to determine whether medical errors are committed when a dispute over medical examination and treatment arises or when a complication develops

4. A fine of from 20,000,000 VND to 30,000,000 VND shall be imposed for harming the health or threatening the life of the practitioner during medical examination and treatment.

5. Remedial measures:

The practitioner must be offered apologies in event of the violations in Point a Clause 2 and Clause 4 of this Article.

SECTION 3. VIOLATIONS AGAINST REGULATIONS ON PHARMACY, COSMETICS, AND MEDICAL EQUIPMENT

Article 37. Violations against regulations on conditions for pharmaceutical trading, pharmaceutical practice certificates, certificate of eligibility for drug business, licenses for drug and drug ingredient business in Vietnam

1. When committing one of the following violations, a drug retailer shall incur a fine of from 3,000,000 VND to 5,000,000 VND, a drug wholesaler, a provider of preservation services, a provider of drug testing services, or a foreign doing drug and drug ingredient business in Vietnam shall incur a fine of from 5,000,000 VND to 8,000,000 VND:

a) The person in charge of expertise being absent without delegating the job to another person;

b) Manufacturing, wholesaling, retailing, providing preservation services or testing services without the certificate of good practice; or using an expired certificate of good practice;

c) Failure to keep a log of the sale and purchase of drugs as prescribed by law.

2. When committing one of the following violations, a drug retailer shall incur a fine of from 5,000,000 VND to 10,000,000 VND, a drug wholesaler, a provider of preservation services, a provider of drug testing services, or a foreign doing drug and drug ingredient business in Vietnam shall incur a fine of from 10,000,000 VND to 20,000,000 VND:

a) Selling drugs without a pharmaceutical practice certificate or while the certificate is being suspended;

b) Selling drugs without a certificate of eligibility for drug business or while the certificate is being suspended;

c) Using a fabricated, rented, or borrowed pharmaceutical practice certificate, certificate of eligibility for drug business, relevant qualifications, or license for drug and drug ingredient business in Vietnam;

d) Selling drugs at a place other than that written in the certificate of eligibility for drug business;

dd) Selling drugs beyond the scope written on the certificate of eligibility for drug business, or providing drugs beyond the license for drug and drug ingredient business in Vietnam.

3. Additional penalties:

a) The pharmaceutical practice certificate shall be suspended for 01 - 03 months in event of the violations mentioned in Point a Clause 1 and Point c Clause 2 of this Article;

b) The certificate of eligibility for drug business or the license for drug and drug ingredient business in Vietnam shall be suspended for 01 - 03 months in event of the violations mentioned in Point d and Point dd Clause 2 of this Article.

Article 38. Violations against regulations on drug registration

1. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Failure to send reports or provide information about the registration of drugs in Vietnam, responsibilities of drug-registering facilities, drug-manufacturing facilities for competent authorities, unless a written satisfactory explanation is provided;

b) Failure to retain and present the application for drug registration and documents about drug batches to competent authorities at their request.

2. A fine of from 5,000,000 VND to 10,000,000 VND shall be imposed for the applicant’s failure to cooperate with the manufacturer, or importer to recall the drugs with inadequate quality, safety, or effectiveness at the request of a competent authority or upon the applicant’s discovery.

3. Any of the following violations shall carry a fine of from 15,000,000 VND to 20,000,000 VND:

a) Failure to notify competent authorities of Vietnam of the drugs that have been banned or have had their registration numbers revoked by the authority of the home country because of their quality, safety, or effectiveness;

b) Providing technical documents and relevant information, including documents about quality standards, manufacturing methods, and stability without actual experiments or manufacturing; providing the application for drug registration that is not conformable with law;

c) Submitting drug samples other than those written in the application for drug registration;

d) Providing documents and information about the effects, safety, and effectiveness of drugs without supporting documents or scientific evidence.

4. Remedial measures:

Competent authorities shall be requested to revoke drug registration numbers in event of the violation mentioned in Point a Clause 3 of this Article.

Article 39. Violations against regulations on drug manufacturing

1. A fine of from 10,000,000 VND to 15,000,000 VND shall be given to any drug manufacturer that commits one of the following violations:

a) Failure to notify competent authorities of minor changes or change of the manufacturing location in the application for drug registration;     

b) Failure to employ qualified for drugs inspection and drug management;

c) Failure to retain drug samples as prescribed by law;

d) Failure to retain drug manufacturing documents as prescribed by law.

2. A fine of from 15,000,000 VND to 25,000,000 VND shall be incurred by any drug manufacturer that commits one of the following violations:

a) Failure to follow the standard operating procedure during the registered drug manufacturing process;

b) Failure to comply with the laws on manufacturing or traditional medicines and herbal medicines;

c) Failure to reach quality standard level 3 as prescribed by law;

d) Manufacturing products other than drugs using the drug manufacturing line.

3. A fine of from 30,000,000 VND to 40,000,000 VND shall be incurred by any drug manufacturer that commits one of the following violations:

a) Failure to comply with the laws on changes to the application for drug registration, except for the case in Point a Clause 1 Article 44 of this Decree;

b) Failure to recall drugs with inadequate quality or safety at the request of competent authorities or upon the manufacturer’s discovery;

c) Failure to reach quality standard level 2 as prescribed by law;

d) Manufacturing drugs for sales after the registration number has expired, unless otherwise permitted the Minister of Health;

dd) Using substandard packages in physical contact with drugs.

4. Any of the following violations shall carry a fine of from 40,000,000 VND to 50,000,000 VND:

a) Manufacturing drugs that fail to reach quality standards level 1 as prescribed by law;

b) Manufacturing drugs at a facility that has not obtained a certificate of eligibility for drug business.

5. Any of the following violations shall carry a fine of from 50,000,000 VND to 70,000,000 VND:

a) Manufacturing drugs for sale without registration number, except for traditional medicines and raw herbal ingredients;

b) Using expired drug ingredients, using ingredients that are not meant for manufacture of drugs for humans, or using the ingredients advised against by WHO or a competent authority because they are not safe for humans;

c) Using ingredients of unknown origins, ingredients that are not undergo quality inspection, or ingredients that fail to reach quality standards to manufacture drugs.

6. Additional penalties:

The certificate of eligibility for drug business shall be suspended for 03 - 06 months in event of the violations mentioned in Point a and Point b Clause 1, Clauses 2, 3, 4, and 5 of this Article.

7. Remedial measures:

a) The drugs or other products of substandard quality shall be destroyed in event of the violations mentioned in Clauses 2, 3, 4, and 5 of this Article;

b) Competent authorities shall be requested to revoke unexpired drug registration numbers in event of the violations mentioned in Point a and Point b Clause 3, Clause 4, Point b and Point c Clause 5 of this Article.

Article 40. Violations against regulations on wholesaling and retailing of drugs

1. A warning or a fine of from 200,000 VND to 500,000 VND shall be imposed for retailing prescription drugs without prescriptions.

2. Any of the following violations shall carry a fine of from 1,000,000 VND to 3,000,000 VND:

a) Retailing preprocessed herbal ingredients that fail to meet the quality standards approved by competent authorities;

b) The drug seller’s or their assistants’ failure to obtain appropriate qualifications as prescribed by law.

3. A fine of from 3,000,000 VND to 5,000,000 VND shall be imposed for selling drugs against the prescription.

4. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to recall drugs or report the recall result at the request of competent authorities;

b) Wholesaling preprocessed herbal ingredients that fail to meet the quality standards approved by competent authorities;

c) Failure to have a preparation room in the drug-retailing store that prepares drugs according to prescriptions;

d) Failure to have a preservation room in the drug-retailing store that registered a preservation room;

dd) Selling drugs that belong to the national programs, selling drugs covered by health insurance, or selling donated drugs that are not for sale, selling drugs provided as humanitarian aid, non-commercial imported drugs, rare drugs, or drugs serving special cases of treatment in the hospitals.

5. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Retailing drugs that fail to reach quality standards or have expired;

b) Selling drugs that have been recalled by a competent authority;

c) Selling drugs that are undergoing a clinical trial; selling drugs that are prepared according to prescriptions meant to be used within the drugstore or medical facility;

d) Selling drug ingredients, finished drugs, vaccines, or biologicals to a facility that is not licensed for drug business;

dd) Wholesaling drugs to an unlawful pharmaceutical facility or one that is not permitted by law to by such drugs.

6. Any of the following violations shall carry a fine of from 40,000,000 VND to 50,000,000 VND:

a) Wholesaling drugs that fail to reach quality standards or have expired;

b) Selling drugs without certificates of free sale;

c) Selling drugs of unknown origins or banned drugs.

7. Additional penalties:

a) The pharmaceutical practice certificate, the certificate of eligibility for drug business shall be suspended for 01 - 03 months if drugs are not recalled at the request of competent authorities according to Point a Clause 4 of this Article;

b) The pharmaceutical practice certificate, the certificate of eligibility for drug business shall be suspended for 03 - 06 months in event of the violations mentioned in Point c, d, dd Clause 4, Points a, b, d, dd Clause 5, and  Clause 6 of this Article.

8. Remedial measures:

a) The illegal money mentioned in Point dd Clause 4, Points a, b, c Clause 5, and Clause 6 of this Article must be returned. Such amount shall be transferred to government budget if the recipients are not identifiable;

b) All of the drugs mentioned in Clause 5 and Clause 6 of this Article shall be destroyed.

Article 41. Violations against regulations on drug export and import

1. Any of the following violations shall carry a fine of from 40,000,000 VND to 50,000,000 VND:

b) Importing drugs without certificates of free sale;

b) Importing a drug after it is banned in its home country;

c) Importing drugs with insufficient remaining shelf life when they arrive at Vietnam’s port without permission of the Minister of Health;

b) Failure to recall drugs with inadequate quality or safety at the request of competent authorities;

dd) Importing drug ingredients, finished drugs, vaccines, or biologicals under entrustment by an entity that does not have a certificate of eligibility for drug business.

2. A fine of from 50,000,000 VND to 70,000,000 VND shall be imposed for import of drugs without acceptable quality and safety, or import of expired drugs.

3. Additional penalties:

The pharmaceutical practice certificate, the certificate of eligibility for drug business shall be suspended for 01 - 03 months in event of the violations mentioned in Points a, b, d Clause 1, and Clause 2 of this Article.

4. Remedial measures:

The drugs or drug ingredients mentioned in Clause 1 and Clause 2 of this Article must be re-exported or removed from Vietnam. Otherwise, they shall be destroyed.

Article 42. Violations against regulations drug preservation

1. A fine of from 500,000 VND to 1,000,000 VND shall be incurred by any drug retailer that commits one of the following violations:

a) Retailing drugs that do not meet preservation conditions on their labels;

b) Failure to separate drugs from other products.

2. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to comply with the regulations on good storage practice introduced by competent authorities;

b) Failure to comply with regulations on drug preservation during the preservation or transportation of drugs;

c) Failure to separate drugs from other products in the drugstore.

3. Additional penalties:

The pharmaceutical practice certificate, the certificate of eligibility for drug business shall be suspended for 01 - 03 months in event of the violations mentioned in Point a and Point b Clause 2 of this Article.

4. Remedial measures:

All of the drugs without acceptable quality mentioned in Point a Clause 1 and Point b Clause 2 of this Article shall be destroyed.

Article 43. Violations against regulations drug testing

1. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to follow the regulations on good laboratory practice in the drug testing facility;

b) Failure to comply with regulations on good testing practice.

2. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Providing drug testing services without permission of the Minister of Health;

b) Falsifying analysis data;

c) Testing the drug samples other than the samples provided by the researching or manufacturing, which are written in the application for drug registration.

3. Additional penalties:

The certificate of eligibility for drug business shall be suspended for 01 - 03 months in event of the violations mentioned in Clause 2 of this Article.

Article 44. Violations against regulations drug packages and labels

1. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Changing the package without permission of competent authorities;

b) Selling drugs without intact packages or labels as described in the granted application.

2. A fine of from 30,000,000 VND to 40,000,000 VND shall be imposed for falsifying the information about expiration dates, indications, contraindications, dosage, and effects on the approved labels, or using labels that are not consistent with the granted application.

3. Additional penalties:

The certificate of eligibility for drug business of the drug seller or the license for drug and drug ingredient business in Vietnam of the drug distributor shall be suspended for 01 - 03 months in event of the violations mentioned in Clause 2 of this Article.

4. Remedial measures:

Illegal drugs in Clause 2 of this Article shall be destroyed.

Article 45. Violations against regulations on addictive drugs, psychotropic drugs, and drug precursors

1. A fine of from 5,000,000 VND to 10,000,000 VND shall be imposed for prescribing, dispensing, or using addictive drugs, psychotropic drugs, and drug precursors against the law.

2. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) Selling or buying addictive drugs, psychotropic medicines, and drug precursors without a plan approved by a competent authority;

b) Preserving, providing addictive drugs, psychotropic drugs, and drug precursors against the law;

c) Transporting, delivery, packaging addictive drugs, psychotropic drugs, and drug precursors against the law.

d) Destroying addictive drugs, psychotropic drugs, and drug precursors against the law;

dd) Failure to keep records of and retain sufficient documents about addictive drugs, psychotropic medicines, and drug precursors;

e) Exporting, importing addictive drugs, psychotropic medicines, and drug precursors without license granted by a competent authority and through an improper border checkpoint.

3. A fine of from 10,000,000 VND to 20,000,000 VND or from 30,000,000 VND to 40,000,000 VND shall be given to any retailer or wholesaler, respectively, that sells addictive drugs, psychotropic drugs, and drug precursors to ineligible users or to a facility that does not have a certificate of eligibility to trade in addictive drugs, psychotropic drugs, and drug precursors.

4. Additional penalties:

The certificate of eligibility for drug business shall be suspended for 01 - 03 months in event of the violations mentioned in Clause 2 and Clause 3 of this Article.

5. Remedial measures:

The drugs mentioned in Point e Clause 2 and Clause 3 of this Article shall be destroyed.

Article 46. Violations against regulations scientific research and clinical trials

1. A fine of from 5,000,000 VND to 10,000,000 VND shall be imposed for concealing information or providing insufficient or untruthful information about the clinical trial for the human test subjects (hereinafter referred to as participants), about the testing process and possible risks.

2. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Providing personal information about participants without their consents;

b) Failure to report the progress or result of the clinical trial as prescribed by law;

c) Failure to comply with regulations on good clinical trial practice.

3. Any of the following violations shall carry a fine of from 50,000,000 VND to 70,000,000 VND:

a) Conducting a clinical trial without permission of the Minister of Health;

b) Changing the clinical trial outlines or documents that have been approved by the Minister of Health;

c) Using experimental drugs for other purposes;

d) Forcing other people to participate in the trial;

dd) Falsifying the clinical trial results.

4. Additional penalties:

The certificate of eligibility for drug business and the certificate of good clinical trial practice shall be suspended for 01 - 03 months in event of the violations mentioned in Clause 2 and Clause 3 of this Article.

Article 47. Violations against regulations on drug price management

1. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Failure to declare or sufficiently declare drug prices as prescribed by law;

b) Failure to adjust the declared prices after a written opinion is given by a competent authority;

c) Selling drugs at a higher price than the declared one;

d) Failure to notify the correct prices that have been declared to customers;

dd) The hospital dispensary purchasing drugs at higher wholesaling prices than that in the declaration, or failing to declare drug prices as prescribed by law.

2. A fine of from 10,000,000 VND to 20,000,000 VND shall be given to any hospital dispensary that sells more drugs at higher prices than the maximum rate of retail profit imposed by competent authorities.

3. A fine of from 20,000,000 VND to 30,000,000 VND shall be imposed for buying drugs of which the difference between the successful bid and the cost price exceeds the maximum rate of retail profit imposed by competent authorities.

4. Remedial measures:

The difference mentioned in Point c Clause 1 of this Article must be returned. Such amount shall be transferred to government budget if the recipients are not identifiable.

Article 48. Violations against regulations on cosmetic notification

1. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) Failure to provide truthful information in the notification of cosmetic products.

b) Failure to notify the cosmetic products before they are release onto the market (applied to domestic cosmetic manufacturers or cosmetic importers).

2. Remedial measures:

A) The illegal cosmetics mentioned in Clause 1 of this Article shall be destroyed;

b) Competent authorities shall be requested to revoke the identification numbers of cosmetic notification in event of the violation mentioned in Point a Clause 1 of this Article.

Article 49. Violations against regulations on information about pharmacy, cosmetics, and medical equipment

1. A warning shall be given to any pharmaceutical sales representative (hereinafter referred to as drug rep) that does not wear a drug rep’s card while working.

2. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Failure to send a notification to the Service of Health when the drug rep works in a province other than that on the drug rep’s card;

b) Holding a conference to introduce drugs before submitting an application for permission to hold the conference to a competent authority, or before the application is granted;

c) Holding a conference or event to introduce cosmetics that is inconsistent with the application granted by a competent authority;

d) Holding a conference or event to introduce cosmetics using expired contents; Holding a conference or event to introduce cosmetics before the application is granted;

dd) Failing to notify the Service of Health of changes in the time and location of the conference or event for cosmetic introduction, which has been approved by Services of Health;

e) The information about medical equipment is not consistent with the application, or the advertisement is not adjusted at the request of a competent authorities;

g) Holding a conference or event to introduce medical equipment before the application is granted by a competent authority.

3. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Providing drug information that is not consistent with that registered with competent authorities; providing drug information before the application is granted; providing drug information according to an expired document; providing drug information before submitting the application for registration to a competent authority, unless the drug information is exempt from registration;

b) Providing information about the drugs that do not have registration numbers or that have expired registration number, except for the drug information exempt from registration and the conferences to introduce drugs to health officials;

c) Failure to monitor and report information about drugs, their harmful effects, new information the drugs, and deterioration in quality of the drugs to the Ministry of Health and National Drug Intelligence Center;

d) Providing inaccurate documents about drug information;

dd) Holding a conference to introduce cosmetics without a identification numbers of cosmetic notification is issued by a competent authority, or before the application for registration is submitted;

e) Declaring that the cosmetics have medicinal effects in a way that make consumers confuse them with drugs;

g) Deliberately concealing information or delaying notifying competent authorities and customers of the problems and side effects of medical equipment.

4. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Providing obscure information about dietary supplements and products other than drugs in a way that make consumers confuse them with drugs;

b) Persuading physicians or patients into prescribing or using drugs by means of financial benefits;

c) Introducing drugs before obtaining a drug rep's card;

d) Failure to provide explanation and rectify illegal information at the request of competent authorities.

5. Remedial measures:

The illegal documents and instruments mentioned in Point b Clause 2, Points a, b, d, dd, and e Clause 3, and Point a Clause 4 of this Article shall be destroyed.

Article 50. Violations against regulations on cosmetics manufacturing

1. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Manufacturing cosmetics without adhering to Cosmetics Good Manufacturing Practice -ASEAN or equivalent practices accredited by ASEAN Cosmetic Committee;

b) Using banned ingredients to manufacture cosmetics, or exceeding the limits on the concentration of restricted substances, or manufacturing cosmetics without acceptable quality and safety;

c) Manufacturing cosmetics of which the formulae are not consistent with the application for notification.

2. Remedial measures:

a) The cosmetics mentioned in Point b and Point c Clause 1 of this Article shall be destroyed;

b) Competent authorities shall be requested to revoke the identification numbers of cosmetic notification in event of the violations mentioned in Point b and Point c Clause 1 of this Article.

Article 51. Violations against regulations on selling cosmetics

1. Any entity that commits one of the following violations shall incur a fine of from 5,000,000 VND to 10,000,000 VND if the value of the illegal shipment is below 20,000,000 VND, or a fine of from 10,000,000 VND to 20,000,000 VND if the value of the illegal shipment is 20,000,000 VND or more:

a) Selling cosmetics without intact packages;

b) Selling contraband cosmetics or cosmetics of unknown origins;

c) Selling expired cosmetics;

d) Selling cosmetics without a notification of cosmetic products;

dd) Selling cosmetics that contain banned substances or the concentration of the restricted substances contained therein exceeds the limits;

e) Selling cosmetics without acceptable quality or safety;

g) Selling the cosmetics that have been recalled by a competent authority;

2. Any entity in charge of launching products that commits one of the following violations shall incur a fine of from 15,000,000 VND to 30,000,000 VND:

A) Selling cosmetics of which the product information files (PIF) are not conformable with law;

b) Selling cosmetics without acceptable quality or safety;

c) Selling cosmetics without intact packages or selling cosmetics of unknown origins;

d) Selling expired cosmetics;

dd) Changing the contents after the cosmetic product is notified without approval by a competent authority; changing the name, address without changing the number of the Certificate of Business registration or certificate of investment; changing the name or address of the importer; changing the representative, changing the design of products;

e) Selling the cosmetics of which the recall is ordered by a competent authority.

3. Any entity in charge of launching products that commits one of the following violations shall incur a fine of from 30,000,000 VND to 40,000,000 VND:

a) Selling cosmetics that contain banned substances or the concentration of the restricted substances contained therein exceeds the limits;

b) Selling cosmetics without PIF as prescribed by law;

c) Selling cosmetics of which the formulae are not consistent with the granted application for notification;

d) Failure to recall cosmetics at the request of competent authorities.

4. Remedial measures:

a) All of the cosmetics mentioned in Clause 1, Points b, c, d, e Clause 2, Point a and Point c Clause 3 of this Article shall be destroyed;

b) Competent authorities shall be requested to revoke the identification numbers of cosmetic notification in event of the violations mentioned in Clause 3 of this Article.

Article 52. Violations against regulations on importing cosmetics

1. A fine of from 10,000,000 VND to 20,000,000 VND shall be imposed for importing cosmetics without intact packages or of unknown origins.

2. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Importing cosmetics that contain banned substances or the concentration of restricted substances contained therein exceeds the limits;

b) Importing a cosmetic after it is banned in its home country.

3. Remedial measures:

a) The cosmetics mentioned in Clause 1 and Clause 2 of this Article shall be destroyed.

b) Competent authorities shall be requested to revoke the identification numbers of cosmetic notification in event of the violations mentioned in Clause 2 of this Article.

Article 53. Violations against regulations on cosmetic labels

1. Any of the following violations shall carry a fine of from 15,000,000 VND to 30,000,000 VND:

a) Failure to declare or sufficiently declare drug prices as prescribed by law;

b) The origin or effects of products on the label are incorrect.

2. Remedial measures:

a) The cosmetics mentioned in Point b Clause 1 of this Article shall be destroyed;

b) Competent authorities shall be requested to revoke the identification numbers of cosmetic notification in event of the violation mentioned in Point b Clause 1 of this Article.

Article 54. Violations against regulations on conditions for selling medical equipment

1. Any of the following violations shall carry a fine of from 5,000,000 VND to 10,000,000 VND:

a) Selling medical equipment without a Certificate of Business registration;

b) The infrastructure, equipment, or personnel serving the manufacture and sale of medical equipment are not conformable with law.

2. Any of the following violations shall carry a fine of from 10,000,000 VND to 20,000,000 VND:

a) Selling medical equipment without a registration number, or import license issued by a competent authority, or a certificate of origin;

b) Selling medical equipment beyond the scope of the registered business.

3. Additional penalties:

The medical equipment mentioned in Point a Clause 2 of this Article shall be confiscated.

Article 55. Violations against regulations on manufacturing medical equipment

1. A fine of from 5,000,000 VND to 10,000,000 VND shall be imposed for the failure to notify the competent authority of the changes in the products, the manufacturing facility, and the person in charge of manufacturing.

2. A fine of from 10,000,000 VND to 20,000,000 VND shall be imposed for avoiding mitigating the harm caused by faulty medical equipment.

3. A fine of from 20,000,000 VND to 30,000,000 VND shall be imposed for manufacturing medical equipment while the certificate of registration or certificate of free sale (CFS) ahs expired, unless otherwise permitted by a competent authority.

4. Any of the following violations shall carry a fine of from 30,000,000 VND to 40,000,000 VND:

a) Manufacturing medical equipment without a certificate of eligibility for medical equipment manufacturing;

b) Manufacturing medical equipment for sale in the home market or for export without a certificate of registration or CFS;

c) Manufacturing medical equipment without conducting clinical trials or running the test on incorrect experimental products

5. Remedial measures:

The medical equipment mentioned in Clause 4 of this Article shall be destroyed or recycled.

Article 56. Violations against regulations on importing medical equipment

1. Any of the following violations shall carry a fine of from 20,000,000 VND to 30,000,000 VND:

a) Importing medical equipment that is banned in the home country, in Vietnam, or by WHO;

b) Importing medical equipment that does not undergo clinical trial as prescribed by law;

c) Failure to test the imported medical equipment that demands high precision;

d) Importing medical equipment that is defective, ineffective, or causing harmful side effects for humans;

dd) Importing used medical equipment for commercial purposes, except for those that are gifts.

2. Additional penalties:

a) The license to import medical equipment shall be suspended for 01 - 03 months in event of the violations mentioned in Clause 1 of this Article;

b) The medical equipment mentioned in Clause 1 of this Article shall be confiscated.

SECTION 4. VIOLATIONS PERTAINING TO HEALTH INSURANCE

Article 57. Violations against regulations on paying health insurance 

1. A warning or a fine of from 50,000 VND to 100,000 VND shall be given to any individual liable for health insurance that fails to pay insurance.

2. A fine of from 300,000 VND to 500,000 VND shall be given to any employer that fails pay compulsory health insurance for every employee liable for health insurance.

3. Any employer that fails to pay health insurance for every employee liable for health insurance shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND if fewer than 10 employees are omitted;

b) A fine of from 1,000,000 VND to 5,000,000 VND if 10 - 49 employees are omitted;

c) A fine of from 5,000,000 VND to 10,000,000 VND if 50 - 99 employees are omitted;

d) A fine of from 10,000,000 VND to 15,000,000 VND if 100 - 499 employees are omitted;

dd) A fine of from 15,000,000 VND to 20,000,000 VND if 500 - 999 employees are omitted;

e) A fine of from 20,000,000 VND to 30,000,000 VND 1,000 employees or more are omitted.

4. Any entity that fails to pay health insurance in full shall be liable to:

a) A fine of from 300,000 VND to 500,000 VND if the arrears are below 5,000,000 VND;

b) A fine of from 500,000 VND to 1,000,000 VND if the arrears are from 5,000,000 VND to below 10,000,000 VND;

c) A fine of from 1,000,000 VND to 2,000,000 VND if the arrears are from 10,000,000 VND to below 20,000,000 VND;

d) A fine of from 3,000,000 VND to 5,000,000 VND if the arrears are from 20,000,000 VND to below 40,000,000 VND;

dd) A fine of from 5,000,000 VND to 10,000,000 VND if the arrears are from 40,000,000 VND to below 60,000,000 VND;

e) A fine of from 10,000,000 VND to 15,000,000 VND if the arrears are from 60,000,000 VND to below 80,000,000 VND;

g) A fine of from 15,000,000 VND to 20,000,000 VND if the arrears are from 80,000,000 VND to below 120,000,000 VND;

h) A fine of from 20,000,000 VND to 25,000,000 VND if the arrears are from 120,000,000 VND to below 160,000,000 VND;

i) A fine of from 25,000,000 VND to 35,000,000 VND if the arrears is 160,000,000 VND or more.

5. Remedial measures:

a) Any entity that commits the violation in Clause 1 of this Article must pay health insurance premium to the account of health insurance fund;

b) In event of the violations in Clause 2 and Clause 3 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable;

c) Any entity that commits the violations in Clause 2, Clause 3 and Clause 4 of this Article must pay health insurance premium and any interest thereon to the account of health insurance fund.

Article 58. Violations against regulations on including external people in the payroll to obtain health insurance

1. Any organization that illegally obtains insurance for other people shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND shall be imposed for every illegal health insurance card has not been used;

b) A fine of from 1,000,000 VND to 2,000,000 VND shall be imposed for every illegal health insurance card that has been used.

2. Every individual that obtains health insurance against the law shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND if the health insurance card is not used;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the health insurance card has been used;

3. Remedial measures:

a) The medical cost covered by health insurance according to Point b Clause 1 and Point b Clause 2 of this Article must be returned;

b) Competent authorities shall be requested to revoke the illegal health insurance cards mentioned in Point b Clause 1 and Point b Clause 2 of this Article.

Article 59. Violations against regulations on incorrectly certify health insurance premium paid by policyholders

Any entity that incorrectly certifies the health insurance premium paid by policyholders shall be liable to:

1. A fine of from 500,000 VND to 1,000,000 VND if the incorrect amount is below 10,000,000 VND;

2. A fine of from 1,000,000 VND to 2,000,000 VND if the incorrect amount is from 10,000,000 VND to below 20,000,000 VND;

3. A fine of from 3,000,000 VND to 5,000,000 VND if the incorrect amount is from 20,000,000 VND to below 40,000,000 VND;

4. A fine of from 5,000,000 VND to 10,000,000 VND if the incorrect amount is from 40,000,000 VND to below 60,000,000 VND;

5. A fine of from 10,000,000 VND to 15,000,000 VND if the incorrect amount is from 60,000,000 VND to below 80,000,000 VND;

6. A fine of from 15,000,000 VND to 20,000,000 VND if the incorrect amount is from 80,000,000 VND to below 100,000,000 VND;

7. A fine of from 20,000,000 VND to 25,000,000 VND if the incorrect amount is from 100,000,000 VND to below 120,000,000 VND;

8. A fine of from 25,000,000 VND to 35,000,000 VND if the incorrect amount is from 120,000,000 VND to below 150,000,000 VND;

9. A fine of from 35,000,000 VND to 45,000,000 VND if the incorrect amount is 150,000,000 VND or more.

Article 60. Violations against regulations on extracting government budget to pay health insurance premium

1. Any entity that improperly extracts government budget to pay health insurance premium but does not cause a loss to the health insurance fund and does not affect the benefits of policyholders shall be given a warning or a fine of from 200,000 VND to 500,000 VND.

2. Any entity that improperly extracts government budget to pay health insurance premium and causes a loss to the health insurance fund or affects the benefits of policyholders shall be liable to:

a) A fine of from 1,000,000 VND to 2,000,000 VND if the incorrect amount is below 500,000,000 VND;

b) A fine of from 3,000,000 VND to 5,000,000 VND if the incorrect amount is from 500,000,000 VND to below 1,000,000,000 VND;

c) A fine of from 5,000,000 VND to 10,000,000 VND if the incorrect amount is from 1,000,000,000 VND to below 5,000,000,000 VND;

d) A fine of from 10,000,000 VND to 20,000,000 VND if the incorrect amount is 5,000,000,000 VND or more.

3. Remedial measures:

The illegal money mentioned in Clause 2 of this Article, including interest thereon, must be returned to the account of health insurance fund.

Article 61. Violations against regulations on extracting government budget to pay health insurance after the procedure is completed

1. Any entity that fails to extracts government budget to pay health insurance within 30 days after the procedure is completed but does not cause a loss to the health insurance fund and does not affect the benefits of policyholders shall be given a warning or a fine of from 200,000 VND to 500,000 VND.

2. Any entity that fails to extracts government budget to pay health insurance within 30 days after the procedure is completed but and causes a loss to the health insurance fund or affects the benefits of policyholders shall be liable to :

a) A fine of from 1,000,000 VND to 2,000,000 VND if the incorrect amount is below 500,000,000 VND;

b) A fine of from 3,000,000 VND to 5,000,000 VND if the incorrect amount from 500,000,000 VND to below 1,000,000,000 VND;

c) A fine of from 5,000,000 VND to 10,000,000 VND if the incorrect amount from 1,000,000,000 VND to below 10,000,000,000 VND;

A fine of from 10,000,000 VND to 20,000,000 VND if the incorrect amount is 10,000,000,000 VND or more.

3. Remedial measures:

a) In event of the violations in Clause 2 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable;

b) The deferred payment (if any) must be transferred to the health insurance account within 10 working days from the day on which the decision on penalties for the violations mentioned in Clause 2 of this Article is received.

Article 62. Violations against regulations on making and sending the list of health insurance policyholders (hereinafter referred to as policyholders)

1. Any of the following violations shall carry a warning or fine of from 200,000 VND to 500,000 VND:

a) Making and sending the list of policyholders under one’s management behind schedule without affecting their benefits;

b) Making and sending an insufficient list of policyholders under one’s management behind schedule without affecting their benefits.

2. Any entity that makes and sends the list of policyholders behind schedule and affects their benefits shall be liable to:

a) A fine of from 500,000 VND to 700,000 VND if the list is sent less than 10 working days behind schedule;

b) A fine of from 700,000 VND to 1,000,000 VND if the list is sent 10 working days or more behind schedule.

3. Any entity that makes and sends an insufficient list of policyholders that affects the benefits of policyholders shall be liable to:

a) A fine of from 300,000 VND to 500,000 VND if fewer than 50 policyholders are omitted from the list;

b) A fine of from 500,000 VND to 1,000,000 VND if 50 - 99 policyholders are omitted from the list;

c) A fine of from 1,000,000 VND to 2,000,000 VND if 100 - 499 policyholders are omitted from the list;

d) A fine of from 3,000,000 VND to 5,000,000 VND if 500 - 999 policyholders are omitted from the list;

dd) A fine of from 5,000,000 VND to 10,000,000 VND if 1,000 policyholders or more are omitted from the list;

4. Remedial measures:

In event of the violations in Clause 2 and Clause 3 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable.

Article 63. Violations against regulations on issuance, reissuance, and replacement of health insurance cards

1. A warning shall be given if the health insurance card is issued, reissued, or replaced less than 10 working days behind schedules.

2. If the health insurance card is issued more than 10 working days behind schedule, the issuer shall be liable to:

a) A fine of from 300,000 VND to 500,000 VND if fewer than 50 cards are issued behind schedule;

b) A fine of from 500,000 VND to 1,000,000 VND if 50 - 99 cards are issued behind schedule;

c) A fine of from 1,000,000 VND to 2,000,000 VND if 100 - 499 cards are issued behind schedule;

d) A fine of from 3,000,000 VND to 5,000,000 VND if 500 - 999 cards are issued behind schedule;

dd) A fine of from 5,000,000 VND to 10,000,000 VND if 1,000 cards or more are issued behind schedule.

3. If the health insurance card is reissued or replaced more than 10 working days behind schedule, the issuer shall be liable to:

a) A fine of from 300,000 VND to 500,000 VND if fewer than 50 cards are reissued or replaced behind schedule;

b) A fine of from 500,000 VND to 1,000,000 VND if 50 - 99 cards are reissued or replaced behind schedule;

c) A fine of from 1,000,000 VND to 2,000,000 VND if 100 - 499 cards are reissued or replaced behind schedule;

d) A fine of from 3,000,000 VND to 5,000,000 VND if 500 - 999 cards are reissued or replaced behind schedule;

dd) A fine of from 5,000,000 VND to 10,000,000 VND if 1,000 cards or more are reissued or replaced behind schedule.

4. Remedial measures:

In event of the violations in Clause 2 and Clause 3 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable.

Article 64. Violations against regulations on issuance health insurance cards

1. If the health insurance card is issued to an ineligible person, the issuer shall be liable to:

a) A fine of from 1,000,000 VND to 2,000,000 VND the card has not been used for medical examination and treatment;

b) A fine of from 3,000,000 VND to 5,000,000 VND if the card has not been used for medical examination and treatment.

2. If the benefits of the policyholder on the health insurance card are incorrect, the issuer shall be liable to:

a) A fine of from 300,000 VND to 500,000 VND the card has not been used for medical examination and treatment;

b) A fine of from 500,000 VND to 1,000,000 VND if the card has not been used for medical examination and treatment.

3. If the expiry date on the health insurance card is incorrect, the issuer shall be liable to:

a) A fine of from 300,000 VND to 500,000 VND the card has not been used for medical examination and treatment;

b) A fine of from 500,000 VND to 1,000,000 VND if the card has not been used for medical examination and treatment.

4. Remedial measures:

a) The medical cost covered by health insurance according to Point b Clause 1 of this Article must be returned to health insurance fund;

b) In event of the violations in Clause 2 and Clause 3 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable;

c) The medical cost covered by health insurance according to Clause 2 of this Article must be returned to health insurance fund;

d) The medical cost covered by health insurance after the expiry date of the health insurance card according to Clause 3 of this Article must be returned to the health insurance fund;

dd) Competent authorities shall be requested to revoke the health insurance cards mentioned in Clause 1, Clause 2 and Clause 3 of this Article.

Article 65. Violations against other regulations on using health insurance cards during medical examination and treatment

1. Any entity that falsifies the health insurance card shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND if the act has not caused a loss to health insurance fund;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the act has caused a loss to health insurance fund.

2. Any individual that lends or borrows the health insurance card shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND if the act has not caused a loss to health insurance fund;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the act has caused a loss to health insurance fund.

3. Remedial measures:

a) The medical cost covered by health insurance according to Point b Clause 1 and Point b Clause 2 of this Article must be returned to health insurance fund;

b) The user of the health insurance card mentioned in Point b Clause 1 and Point b Clause 2 of this Article must repay the medical cost covered by health insurance to the health insurance fund;

c) Competent authorities shall be requested to revoke the health insurance cards mentioned in Clause 1 of this Article.

Article 66. Making fictitious medical records or giving fictitious prescriptions without actual patients

1. Any entity that makes a fictitious medical record or gives a fictitious prescription that is assessed at below 1,000,000 VND and does not constitute a criminal offense shall be given a warning

2. Any entity that makes a fictitious medical record or gives a fictitious prescription that does not constitute a criminal offense shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND if the violation is assessed at from 1,000,000 VND to below 2,000,000 VND;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the violation is assessed at from 2,000,000 VND to below 5,000,000 VND;

c) A fine of from 3,000,000 VND to 5,000,000 VND if the violation is assessed at from 5,000,000 VND to below 10,000,000 VND;

d) A fine of from 5,000,000 VND to 10,000,000 VND if the violation is assessed at from 10,000,000 VND to below 15,000,000 VND;

dd) A fine of from 10,000,000 VND to 15,000,000 VND if the violation is assessed at from 15,000,000 VND to below 25,000,000 VND;

e) A fine of from 15,000,000 VND to 20,000,000 VND if the violation is assessed at from 25,000,000 VND to below 50,000,000 VND;

g) A fine of from 20,000,000 VND to 25,000,000 VND if the violation is assessed at from 50,000,000 VND to below 80,000,000 VND;

h) A fine of from 25,000,000 VND to 30,000,000 VND if the violation is assessed at 80,000,000 VND or more.

3. Remedial measures:

The illegal money mentioned in Clause 1 and Clause 2 of this Article must be returned to the health insurance fund.

Article 67. Violations against regulations on management of drugs, medical supplies, technical services, sickbed costs, and other costs of medical examination and treatment covered by health insurance

1. The following violations shall face a warning or a fine of from 50,000 VND to 100,000 VND if the loss incurred by the health insurance fund is less than 1,000,000 VND:

a) Overstating the quantities of drugs, medical supplies, technical services, and other services that are not used by the patients;

b) Providing inadequate drugs, substances, medical supplies, or technical services during the medical examination and treatment covered by health insurance.

2. Any entity that overstates the quantities of drugs, medical supplies, technical services, and other services that are not used by the patients shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND if the overstated value is from 1,000,000 VND to below 2,000,000 VND;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the overstated value is from 2,000,000 VND to below 5,000,000 VND;

c) A fine of from 3,000,000 VND to 5,000,000 VND if the overstated value is from 5,000,000 VND to below 10,000,000 VND;

d) A fine of from 5,000,000 VND to 10,000,000 VND if the overstated value is from 10,000,000 VND to below 20,000,000 VND;

dd) A fine of from 10,000,000 VND to 15,000,000 VND the overstated value is from 20,000,000 VND to below 30,000,000 VND;

e) A fine of from 15,000,000 VND to 20,000,000 VND if the overstated value is from 30,000,000 VND to below 40,000,000 VND;

g) A fine of from 20,000,000 VND to 25,000,000 VND if the overstated value is from 40,000,000 VND to below 50,000,000 VND;

h) A fine of from 25,000,000 VND to 30,000,000 VND if the overstated value is from 50,000,000 VND to below 60,000,000 VND;

i) A fine of from 30,000,000 VND to 40,000,000 VND if the overstated value is from 60,000,000 VND or more.

3. Any entity that provides inadequate drugs, substances, medical supplies, or technical services during the medical examination and treatment covered by health insurance shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND if the violation is assessed at from 1,000,000 VND to below 10,000,000 VND;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the violation is assessed at from 10,000,000 VND to below 20,000,000 VND;

c) A fine of from 3,000,000 VND to 5,000,000 VND if the violation is assessed at from 20,000,000 VND to below 40,000,000 VND;

d) A fine of from 5,000,000 VND to 10,000,000 VND if the violation is assessed at from 40,000,000 VND to below 80,000,000 VND;

dd) A fine of from 10,000,000 VND to 20,000,000 VND if the violation is assessed at from 80,000,000 VND to below 120,000,000 VND;

e) A fine of from 20,000,000 VND to 40,000,000 VND if the violation is assessed at from 120,000,000 VND to below 160,000,000 VND;

g) A fine of from 40,000,000 VND to 50,000,000 VND if the violation is assessed at 160,000,000 VND or more.

4. Remedial measures:

a) The illegal money mentioned in Point a Clause 1 and Clause 2 of this Article must be returned to the health insurance fund;

b) In event of the violations in Clause 1, Clause 2, and Clause 3 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable.

Article 68. Infringements of the benefits of policyholders

1. A warning or a fine of from 200,000 VND to 500,000 VND shall be imposed if the benefits infringed upon are assessed at below 1,000,000 VND.

2. Any entity that infringes upon the benefits of the policyholders shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND if the benefits infringed upon are assessed at from 1,000,000 VND to below 5,000,000 VND;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the benefits infringed upon are assessed at from 5,000,000 VND to below 10,000,000 VND;

c) A fine of from 2,000,000 VND to 3,000,000 VND if the benefits infringed upon are assessed at from 10,000,000 VND to below 15,000,000 VND;

d) A fine of from 3,000,000 VND to 4,000,000 VND if the benefits infringed upon are assessed at from 15,000,000 VND to below 20,000,000 VND;

dd) A fine of from 4,000,000 VND to 5,000,000 VND if the benefits infringed upon are assessed at from 20,000,000 VND to below 40,000,000 VND;

e) A fine of from 5,000,000 VND to 6,000,000 VND if the benefits infringed upon are assessed at 40,000,000 VND or more.

3. Remedial measures:

a) In event of the violations in Clause 1 and Clause 2 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable;

b) The loss incurred by the health insurance fund must be reimbursed in event of the violations mentioned in Clause 1 and Clause 2 of this Article.

Article 69. Violations against other regulations on payment for medical cost covered by health insurance

1. Any entity that fixes incorrect prices, writes incorrect categories, units, or names of the services in the invoices for medical services covered by health insurance shall be given a warning or liable to a fine of from 200,000 VND to 500,000 VND if the violation is assessed at below 1,000,000 VND.

2. Any entity that fixes incorrect prices, writes incorrect categories, units, or names of the services in the invoices for medical services covered by health insurance shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND if the violation is assessed at from 1,000,000 VND to below 5,000,000 VND;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the violation is assessed at from 5,000,000 VND to below 10,000,000 VND;

c) A fine of from 3,000,000 VND to 5,000,000 VND if the violation is assessed at from 10,000,000 VND to below 20,000,000 VND;

d) A fine of from 5,000,000 VND to 10,000,000 VND if the violation is assessed at from 20,000,000 VND to below 40,000,000 VND;

dd) A fine of from 10,000,000 VND to 20,000,000 VND if the violation is assessed at from 40,000,000 VND to below 80,000,000 VND;

e) A fine of from 20,000,000 VND to 40,000,000 VND if the violation is assessed at from 80,000,000 VND to below 120,000,000 VND;

g) A fine of from 40,000,000 VND to 50,000,000 VND if the violation is assessed at 120,000,000 VND or more.

3. Remedial measures:

a) The illegal money mentioned in Clause 1 and Clause 2 of this Article must be returned to the health insurance fund;

b) In event of the violations in Clause 1 and Clause 2 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable.

Article 70. Violations against regulations on verification of health insurance card

1. A warning or a fine of from 200,000 VND to 500,000 VND shall be given to any entity that commits one of the following violations without affecting the policyholders’ benefits, the medical facility, and the health insurance fund:

a) Failure to verify health insurance in a transparent manner;

b) Obstruction to health insurance verification.

2. Any entity that fails to verify health insurance in a transparent manner or obstructs the verification of health insurance and affects the policyholders’ benefits, the medical facility, or the health insurance fund shall be liable to a fine of from 500,000 VND to 1,000,000 VND.

3. Remedial measures:

a) The illegal money (if any) must be returned to the medical facility in event of the violation in Clause 2 of this Article;

b) In event of the violations in Clause 2 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable.

Article 71. Violations against other regulations on health insurance contracts

1. A warning or a fine of from 200,000 VND to 500,000 VND shall be given to any entity that commits one of the following violations without affecting the benefits of the policyholder, the medical facility, and the health insurance fund:

a) Unilaterally terminating the health insurance contract;

b) Signing a health insurance contract with illegal contents;

c) Signing a health insurance contract beyond one’s competence.

2. Any entity that unilaterally terminates the health insurance contract in a way that infringes upon the benefits of policyholder, the medical facility, or the health insurance fund shall be liable to:

a) A fine of from 1,000,000 VND to 5,000,000 VND if the violation is assessed at below 50,000,000 VND;

b) A fine of from 5,000,000 VND to 10,000,000 VND if the violation is assessed at from 50,000,000 VND to below 100,000,000 VND;

c) A fine of from 10,000,000 VND to 15,000,000 VND if the violation is assessed at from 100,000,000 VND to below 500,000,000 VND;

d) A fine of from 15,000,000 VND to 20,000,000 VND if the violation is assessed at from 500,000,000 VND to below 1,000,000,000 VND;

dd) A fine of from 20,000,000 VND to 30,000,000 VND if the violation is assessed at from 1,000,000,000 VND to below 5,000,000,000 VND;

e) A fine of from 30,000,000 VND to 40,000,000 VND if the violation is assessed at 5,000,000,000 VND or more.

3. Any entity that signs a health insurance contract with illegal contents or beyond its competence in a way that infringes upon the benefits of the policyholders, the medical facility, or the health insurance fund shall be liable to:

a) A fine of from 1,000,000 VND to 5,000,000 VND if the violation is assessed at below 50,000,000 VND;

b) A fine of from 5,000,000 VND to 10,000,000 VND if the violation is assessed at from 50,000,000 VND to below 100,000,000 VND;

c) A fine of from 10,000,000 VND to 15,000,000 VND if the violation is assessed at from 100,000,000 VND to below 500,000,000 VND;

d) A fine of from 15,000,000 VND to 20,000,000 VND if the violation is assessed at from 500,000,000 VND to below 1,000,000,000 VND;

dd) A fine of from 20,000,000 VND to 30,000,000 VND if the violation is assessed at from 1,000,000,000 VND to below 5,000,000,000 VND;

e) A fine of from 30,000,000 VND to 40,000,000 VND if the violation is assessed at 5,000,000,000 VND or more.

4. Remedial measures:

a) Any loss incurred by the health insurance fund or the medical facility must be reimbursed in event of the violation in Clause 2 of this Article;

b) Any loss incurred by policyholders must be reimbursed in event of the violations in Clause 2 of this Article. Such amounts shall be transferred to government budget if the recipients are not identifiable;

c) The illegal money (if any) must be returned to the health insurance fund in event of the violation mentioned in Clause 3 of this Article;

d) Any loss incurred by the medical facility must be reimbursed in event of the violation in Clause 3 of this Article;

dd) In event of the violations in Clause 3 of this Article, the policyholders must be reimbursed for the  medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable.

Article 72. Violations against other regulations on advance payment and payment for medical cost covered by health insurance

1. Any of the following violations shall carry a warning or fine of from 200,000 VND to 500,000 VND:

a) Making illegal advance payment or payment that is below 20,000,000 VND for the medical cost covered by health insurance to medical facilities;

b) Making advance payment or payment for the medical cost covered by health insurance to medical facilities behind schedule without affecting the benefits of such medical facilities and the policyholders.

2. The illegal advance payment or payment the medical cost covered by health insurance shall carry:

a) A fine of from 1,000,000 VND to 2,000,000 VND if the illegal payment is from 20,000,000 VND to below 40,000,000 VND;

b) A fine of from 3,000,000 VND to 5,000,000 VND if the illegal payment is from 40,000,000 VND to below 80,000,000 VND;

c) A fine of from 5,000,000 VND to 10,000,000 VND if the illegal payment is from 80,000,000 VND to below 100,000,000 VND;

d) A fine of from 10,000,000 VND to 15,000,000 VND if the illegal payment is from 100,000,000 VND to below 500,000,000 VND;

dd) A fine of from 15,000,000 VND to 20,000,000 VND if the illegal payment is 500,000,000 VND or more.

3. Late advance payment or payment for the medical cost covered by health insurance shall carry:

a) A fine of from 5,000,000 VND to 10,000,000 VND if the payment made less than 30 days behind schedule;

b) A fine of from 10,000,000 VND to 20,000,000 VND if the payment made ≥ 30 days behind schedule.

4. Remedial measures:

a) Any loss incurred by the medical facility in event of the violation in Point a Clause 1 and Clause 2 of this Article must be reimbursed;

b) The policyholders must be reimbursed for the medical cost covered by health insurance they have paid in event of the violations in Clause 3 of this Article. Such amount shall be transferred to government budget if the recipients are not identifiable.

Article 73. Violations against regulations on using the health insurance fund

1. Any entity that uses the health insurance fund against the law shall be liable to:

a) A fine of from 2,000,000 VND to 5,000,000 VND if the violation is assessed at below 50,000,000 VND;

b) A fine of from 5,000,000 VND to 10,000,000 VND if the violation is assessed at from 50,000,000 VND to below 100,000,000 VND;

c) A fine of from 10,000,000 VND to 20,000,000 VND if the violation is assessed at from 100,000,000 VND to below 500,000,000 VND;

d) A fine of from 20,000,000 VND to 30,000,000 VND if the violation is assessed at from 500,000,000 VND to below 1,000,000,000 VND;

dd) A fine of from 30,000,000 VND to 40,000,000 VND if the violation is assessed at 1,000,000,000 VND or more.

2. Remedial measures:

The illegal money (if any) must be returned to the health insurance fund in event of the violation mentioned in Clause 1 of this Article.

Article 74. Offering benefits inconsistent with the health insurance card

1. Any entity that offers benefits inconsistent with the health insurance card shall be given a warning or a fine of from 200,000 VND to 500,000 VND if the violation is assessed at below 1,000,000 VND.

2. Any entity that offers benefits inconsistent with the health insurance card shall be liable to:

a) A fine of from 500,000 VND to 1,000,000 VND if the violation is assessed at from 1,000,000 VND to below 5,000,000 VND;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the violation is assessed at from 5,000,000 VND to below 10,000,000 VND;

c) A fine of from 2,000,000 VND to 3,000,000 VND if the violation is assessed at from 10,000,000 VND to below 15,000,000 VND;

d) A fine of from 3,000,000 VND to 4,000,000 VND if the violation is assessed at from 15,000,000 VND to below 20,000,000 VND;

Dd) A fine of from 4,000,000 VND to 5,000,000 VND if the violation is assessed at from 20,000,000 VND to below 40,000,000 VND;

e) A fine of from 5,000,000 VND to 6,000,000 VND if the violation is assessed at 40,000,000 VND or more.

3. Remedial measures:

a) In event of the violations in Clause 1 and Clause 2 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable;

b) Any loss incurred by the medical facility must be reimbursed in event of the violation in Clause 1 or Clause 2 of this Article;

c) The illegal money (if any) must be returned to the health insurance fund in event of the violations mentioned in Clause 1 and Clause 2 of this Article;

Article 75. Violations against regulations on health insurance reporting

1. A fine of from 500,000 VND to 1,000,000 VND shall be imposed for the failure to report health insurance on schedule, failure to provide data or to provide accurate data for competent authorities that does not affect the administration and provision of health insurance.

2. A fine of from 5,000,000 VND to 10,000,000 VND shall be imposed for the failure to report health insurance on schedule, failure to provide data or to provide accurate data for competent authorities that affects the administration and provision of health insurance.

Article 76. Improper provision of information about policyholders and health insurance fund used at medical facilities

1. A fine of from 200,000 VND to 500,000 VND shall be imposed for the failure to provide information or to provide correct information about policyholders and health insurance fund used at the medical facility that does not cause a loss for the health insurance fund.

2. The failure to provide information or to provide correct information about policyholders and health insurance fund used at the medical facility that causes a loss for the health insurance fund shall carry:

a) A fine of from 1,000,000 VND to 2,000,000 VND if the violation is assessed at below 50,000,000 VND;

b) A fine of from 3,000,000 VND to 5,000,000 VND if the violation is assessed at from 50,000,000 VND to below 100,000,000 VND;

c) A fine of from 5,000,000 VND to 10,000,000 VND if the violation is assessed at from 100,000,000 VND to below 200,000,000 VND;

d) A fine of from 10,000,000 VND to 20,000,000 VND if the violation is assessed at 200,000,000 VND or more.

Article 77. Improper provision of information about provision of benefits for patients at medical facilities or direct payment to policyholders

1. A fine of from 200,000 VND to 500,000 VND shall be imposed for the failure to provide information or to provide sufficient and correct information about provision of benefits for patients at medical facilities or direct payment to policyholders that does not affect the policyholders’ benefits.

2. A fine of from 500,000 VND to 1,000,000 VND shall be imposed for the failure to provide information or to provide sufficient and correct information about provision of benefits for patients at medical facilities or direct payment to policyholders that affects the policyholders’ benefits.

3. Remedial measures:

In event of the violations in Clause 2 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable.

Article 78. Late submission of statement of medical cost covered by health insurance

1. A warning or a fine of from 200,000 VND to 500,000 VND shall be imposed if the statement of medical cost covered by health insurance is submitted less than 05 working days behind schedule.

2. The late submission of the statement of medical cost covered by health insurance shall carry:

a) A fine of from 3,000,000 VND to 5,000,000 VND if it is 05 - 19 working days behind schedule;

b) A fine of from 5,000,000 VND to 7,000,000 VND if it is 20 working days behind schedule or more.

Article 79. Violations against regulations on health insurance

1. Any of the following violations shall carry a warning or fine of from 200,000 VND to 500,000 VND:

a) Obstruction of the medical examination and treatment covered by health insurance that does not affect the benefits of the policyholders or the medical facility;

b) Failure to comply with regulations of competent authorities that does not affect the benefits of the policyholders or the medical facility;

c) Abuse of covered medical services such as excessive use of drugs, substances, supplies, and medical services that causes a loss of below 1,000,000 VND for the policyholders, the health insurance fund, and the medical facility

2. The obstruction of the medical examination and treatment covered by health insurance that affects the benefits of the policyholders or the medical facility shall carry:

a) A fine of from 500,000 VND to 1,000,000 VND if the violation is assessed at from 1,000,000 VND to below 5,000,000 VND;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the violation is assessed at from 5,000,000 VND to below 10,000,000 VND;

c) A fine of from 2,000,000 VND to 3,000,000 VND if the violation is assessed at from 10,000,000 VND to below 15,000,000 VND;

d) A fine of from 3,000,000 VND to 5,000,000 VND if the violation is assessed at from 15,000,000 VND to below 20,000,000 VND;

dd) A fine of from 5,000,000 VND to 10,000,000 VND if the violation is assessed at from 20,000,000 VND to below 40,000,000 VND;

e) A fine of from 10,000,000 VND to 15,000,000 VND if the violation is assessed at 40,000,000 VND or more.

3. The failure to comply with regulations of competent authorities that affects the benefits of the policyholders, the medical facility, or the health insurance fund shall carry:

a) A fine of from 1,000,000 VND to 5,000,000 VND if the violation is assessed at below 20,000,000 VND;

b) A fine of from 5,000,000 VND to 10,000,000 VND if the violation is assessed at from 20,000,000 VND to below 40,000,000 VND;

C) A fine of from 10,000,000 VND to 20,000,000 VND if the violation is assessed at from 40,000,000 VND to below 80,000,000 VND;

d) A fine of from 20,000,000 VND to 30,000,000 VND if the violation is assessed at from 80,000,000 VND to below 160,000,000 VND;

dd) A fine of from 30,000,000 VND to 40,000,000 VND if the violation is assessed at 160,000,000 VND or more.

4. The abuse of covered medical services such as excessive use of drugs, substances, supplies, and medical services that affects the benefits the policyholders, the health insurance fund, or the medical facility shall carry:

a) A fine of from 500,000 VND to 1,000,000 VND if the violation is assessed at from 1,000,000 VND to below 5,000,000 VND;

b) A fine of from 1,000,000 VND to 2,000,000 VND if the violation is assessed at from 5,000,000 VND to below 10,000,000 VND;

c) A fine of from 3,000,000 VND to 5,000,000 VND if the violation is assessed at from 10,000,000 VND to below 20,000,000 VND;

d) A fine of from 5,000,000 VND to 10,000,000 VND if the violation is assessed at from 20,000,000 VND to below 40,000,000 VND;

dd) A fine of from 10,000,000 VND to 20,000,000 VND if the violation is assessed at from 40,000,000 VND to below 60,000,000 VND;

e) A fine of from 20,000,000 VND to 30,000,000 VND if the violation is assessed at from 60,000,000 VND to below 80,000,000 VND;

g) A fine of from 30,000,000 VND to 40,000,000 VND if the violation is assessed at 80,000,000 VND or more.

5. Remedial measures:

a) In event of the violations in Clause 2 of this Article, the policyholders must be reimbursed for the medical cost covered by health insurance they have paid. Such amounts shall be transferred to government budget if the recipients are not identifiable;

b) Any loss incurred by the medical facility must be reimbursed in event of the violations mentioned in Point c Clause 1 and Clause 2 of this Article;

c) Any loss incurred by any organization or individual must be reimbursed in event of the violation in Clause 3 of this Article. Such amounts shall be transferred to government budget if the recipients are not identifiable;

d) Any loss incurred by policyholders must be reimbursed in event of the violations mentioned in Point c Clause 1 and Clause 4 of this Article. Such amounts shall be transferred to government budget if the recipients are not identifiable;

dd) The illegal money mentioned (if any) must be returned to the health insurance fund in event of the violations mentioned in Point c Clause 1 and Clause 4 of this Article.

SECTION 5. VIOLATIONS PERTAINING TO POPULATION

Article 80. Violations against regulations on dissemination of information about population

1. Any of the following violations shall carry a warning or fine of from 200,000 VND to 500,000 VND:

a) Verbally or physically obstructing the dissemination of information and counseling on birth control;

b) Taking advantages of faiths, religions, and archaic traditions to obstruct the education and counseling about birth control.

2. The dissemination of information that contravenes the state policies and laws on population shall receive a warning or carry a fine of from 3,000,000 VND to 5,000,000 VND.

3. Additional penalties:

The violations mentioned in Clause 2 of this Article are punishable by confiscation of the illegal instruments.

4. Remedial measures:

a) The documents that contravene the state policies and laws on population mentioned in Clause 2 of this Article shall be destroyed;

b) The false information about state policies and laws on population mentioned in Clause 2 of this Article must be rectified.

Article 81. Violations against regulations on spreading instructions about sex selection

1. Any of the following violations shall carry a fine of from 1,000,000 VND to 2,000,000 VND:

a) Spreading instructions on sex selection;

b) Offering instructions on sex selection.

2. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Selling, renting out, dispensing, or posting on the Internet the publications that contain instructions on sex selection;

b) Posting or broadcasting instructions on sex selection.

3. The publishing of publications that contain instructions on sex selection shall incur a fine of from 10,000,000 VND to 15,000,000 VND.

4. Additional penalties:

All illegal items mentioned in Point a Clause 2 of this Article shall be confiscated.

5. Remedial measures:

a) The documents and items used for spreading the instructions on sex selection mentioned in Point a Clause 1 and Clause 3 of this Article shall be destroyed;

b) The instructions on sex selection mentioned in Point a Clause 2 of this Article must be removed.

Article 82. Telling baby’s sex

1. A fine of from 3,000,000 VND to 5,000,000 VND shall be imposed telling the baby’s sex by means of fortune-telling.

2. A fine of from 5,000,000 VND to 10,000,000 VND shall be imposed telling the baby’s sex by means of ultrasound or medical test, unless otherwise prescribed by law.

3. Additional penalties:

The violation mentioned in Clause 2 of this Article shall lead to a suspension of the practising certificate and practising certificate for 01 - 03 months.

Article 83. Violations against regulations on sex selection

1. A fine of from 3,000,000 VND to 5,000,000 VND shall be imposed for intimidating a person into selecting the baby’s sex.

2. A fine of from 7,000,000 VND to 10,000,000 VND shall be imposed for the use of force to make a person select the baby’s sex.

3. Any of the following violations shall carry a fine of from 10,000,000 VND to 15,000,000 VND:

a) Prescribing drugs for selecting baby’s sex;

b) Providing drugs for selecting baby’s sex;

c) Researching methods for sex selection, unless otherwise permitted by law.

4. Additional penalties:

a) The illegal items mentioned in Clause 3 of this Article shall be confiscated;

b) The medical operation or research shall be suspended for 01 - 03 months in event of the violations mentioned in Point a and Point c Clause 3 of this Article;

c) The drug business shall be suspended for 01 - 03 months in event of the violation mentioned in Point b Clause 3 of this Article.

Article 84. Sex-selective abortion

1. Any person that voluntarily decides to have an abortion because of the baby’s sex shall be liable to a fine of from 3,000,000 VND to 5,000,000 VND.

2. Any person that persuades another person into abortion because of the baby’s sex shall be liable to a fine of from 5,000,000 VND to 7,000,000 VND.

3. Any person that intimidates another person into abortion because of the baby’s sex shall be liable to a fine of from 7,000,000 VND to 10,000,000 VND.

4. The use of force to compel another person into abortion because of the baby’s sex shall carry a fine of from 10,000,000 VND to 12,000,000 VND.

5. Any of the following violations shall carry a fine of from 12,000,000 VND to 15,000,000 VND:

a) Providing substances or drugs to abort a child in the knowledge that the abortion is sex-selective;

b) Prescribing substances, drugs, or other measures to abort a child in the knowledge that the abortion is sex-selective.

6. Any person that performs an abortion in the knowledge that the abortion is sex-selective shall be liable to a fine of from 15,000,000 VND to 20,000,000 VND.

7. Additional penalties:

a) The items serving the commitment of the violation mentioned in Point a Clause 5 of this Article shall be confiscated;

b) The operating license or practising certificate shall be suspended for 03 - 06 months in event of the violation mentioned in Point b Clause 5 of this Article;

c) The operating license or practising certificate shall be suspended for 06 - 12 months in event of the violation mentioned in Clause 6 of this Article;

d) The drug business shall be suspended for 01 - 03 months in event of the violation mentioned in Point a Clause 5 of this Article.

Article 85. Obstruction or enforcement of birth control

1. Any of the following violations shall carry a warning or fine of from 100,000 VND to 300,000 VND:

a) Failure to provide complementary birth control instruments for eligible individuals as prescribed by law;

b) Verbally or physically offending the people to that practice birth control or the people that have only boys or only girls.

2. A fine of from 1,000,000 VND to 2,000,000 VND shall be imposed for intimidating another person into using contraception.

3. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Intimidating another person into using or stopping using contraception;

b) Intimidating another person to conceive or give birth while the person has only boys or only girls;

4. A fine of from 5,000,000 VND to 7,000,000 VND shall be imposed for the use of force to compel another person to use contraception.

5. Any of the following violations shall carry a fine of from 7,000,000 VND to 10,000,000 VND:

a) Inserting intrauterine devices, injecting or implanting contraceptives without the user’s consent;

b) Using force to compel another person to not use contraception or to stop using contraception;

c) Using force to compel another person to conceive or give birth while the person has only boys or only girls.

6. A fine of from 20,000,000 VND to 30,000,000 VND shall be imposed for sterilizing a person without the person’s consent.

7. Additional penalties:

The practising certificate shall be suspended for 01 - 03 months in event of the violation mentioned in Clause 6 of this Article.

8. Remedial measures:

The inserted intrauterine devices or implanted contraceptives mentioned in Point a Clause 5 of this Article must be removed.

Article 86. Violations against regulations on selling contraceptives

1. A fine of from 1,000,000 VND to 3,000,000 VND shall be given to any entity that sells contraceptives that are required by competent authorities to be provided free of charge.

2. A fine of from 3,000,000 VND to 5,000,000 VND shall be given to any entity that sells contraceptives at higher prices than those fixed by competent authorities.

3. Additional penalties:

The illegal items serving the commitment of the violation mentioned in Clause 1 of this Article shall be confiscated.

4. Remedial measures:

a) The illegal money mentioned in Clause 1 of this Article must be returned. Such amount shall be transferred to government budget if the recipients are not identifiable;

b) The difference mentioned in Clause 2 of this Article must be returned. Such amount shall be transferred to government budget if the recipients are not identifiable.

SECTION 6. OTHER ADMINISTRATIVE VIOLATIONS AGAINST MEDICINE LAWS

Article 87. Violations against regulations on promoting breastfeeding

1. A fine of from 1,000,000 VND to 2,000,000 VND shall be given to any entity that publishes documents about breastfeeding promotion that fails to include one of the following contents:

a) Benefits and excellence of breastfeeding, the assertion that breast-milk is the best food for the health and comprehensive development of children; the antibacterial elements, especially antibodies contained only in breast-milk that protect children from diarrhoea, Respiratory tract infection and other infections;

b) Instructions on exclusive breastfeeding for the first six months of life, keeping feeding the child with breast-milk until 24 months of age or longer, and starting to feed the child with appropriate food form 06 months of age;

c) Disadvantages of feeding the child with other foods instead of breast-milk such as: high prices, time-consuming, and risk of infection due to improper preparation of milk;

d) Negative effects of bottle-feeding, sucking artificial teats, or eating supplementary foods before 06 months of age;

dd) Instructions on convenient, safe, and nutritious methods for preparing, preserving, and using supplementary foods for children from existing foods;

e) Appropriate diets for maintaining mother’s milk supply.

2. A fine of from 3,000,000 VND to 5,000,000 VND shall be given to any entity that publishes documents about breastfeeding promotion that contain:

a) Pictures or words encouraging feeding children with dairy products other than breast-milk, bottle-feeding, or disapproval of breastfeeding;

b) Statements that breast-milk substitutes are equivalent to or better than breast-milk;

c) Names of symbols of breast-milk substitutes or artificial teats.

Article 88. Violations against regulations on selling and using dietary products for small children

1. Any of the following violations shall carry a fine of from 1,000,000 VND to 2,000,000 VND:

a) Failure to provide accurate information and instructions on proper use of dietary products for small children for physicians, health workers, and consumers;

b) Requesting employees to approach and encourage mothers, pregnant women or their families, whether inside or outside medical facilities, to use breast-milk substitutes.

2. Any of the following violations shall carry a fine of from 3,000,000 VND to 5,000,000 VND:

a) Giving breast-milk substitutes as gifts; provide benefits in kind or other items that bear the name or symbol of a breast-milk substitute for physicians, health workers or medical facilities;

b) Introduction of breast-milk substitutes in the form of scholarships, sponsorships for scientific research, financial support for training, conventions, conferences, courses, concerts, counseling services by phone, or other forms.

3. Any of the following violations shall carry a fine of from 10,000,000 VND to 15,000,000 VND:

a) Displaying breast-milk substitutes and foods for children under 06 months of age at medical facilities;

b) Running sales promotions of breast-milk substitutes such as giving samples, vouchers, prizes, gifts, credits, discounts, or any other pictures for retailing.

Chapter 3.

ENTITLEMENTS TO IMPOSE PENALTIES FOR ADMINISTRATIVE VIOLATIONS AGAINST MEDICINE LAWS

Article 89. Entitlements of Presidents of the People’s Committees to impose penalties

1. Presidents of the People’s Committees of communes are entitled to:

a) Give warning;

b) Impose a fine of up to 3,000,000 VND for every violation pertaining to population; up to 5,000,000 VND for every violation pertaining to defensive medicine, HIV/AIDS prevention, health insurance, medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment;

b) Confiscate illegal items the value of which does not exceed the rate of fine mentioned in Point b of this Clause;

dd) Take the remedial measures mentioned in Point a, Point c, and Point dd Clause 1 Article 28 of the Law on Penalties for administrative violations.

2. Presidents of the People’s Committees of districts are entitled to:

a) Give warning;

b) Impose a fine of up to 15,000,000 VND for every violation pertaining to population; up to 25,000,000 VND for every violation pertaining to defensive medicine, HIV/AIDS prevention; up to 37,500,000 VND for every violation pertaining to health insurance; up to 50,000,000 VND for every violation pertaining to medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment;

c) Suspend the practising certificate or license;

d) Confiscate illegal items the value of which does not exceed the rate of fine mentioned in Point b of this Clause;

dd) Take the remedial measures mentioned in Points a, c, dd, e, h, and i Clause 1 Article 28 of the Law on Penalties for administrative violations and the those in Article 3 of this Decree.

3. Presidents of the People’s Committees of provinces are entitled to:

a) Give warning;

b) Impose a fine of up to 30,000,000 VND for every violation pertaining to population; up to 50,000,000 VND for every violation pertaining to defensive medicine, HIV/AIDS prevention; up to 75,000,000 VND for every violation pertaining to health insurance; up to 100,000,000 VND for every violation pertaining to medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment;

c) Suspend the practising certificate or license, or suspend the operation;

d) Confiscate illegal items;

dd) Take the remedial measures mentioned in Article 3 of this Article.

Article 90. Entitlements of health inspectors to impose penalties

1. Inspectors on duty and the persons assigned to carry out inspections are entitled to:

a) Give warning;

b) Impose a fine of up to 300,000 VND for every violation pertaining to population; up to 500,000 VND for every violation pertaining to defensive medicine, HIV/AIDS prevention, health insurance, medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment;

c) Confiscate illegal items the value of which does not exceed the rate of fine mentioned in Point b of this Clause;

dd) Take the remedial measures mentioned in Point a, Point c, and Point dd Clause 1 Article 28 of the Law on Penalties for administrative violations.

2. Chief inspectors of Services of Health and Directors of Sub-departments of Population and Birth Control affiliated to Services of Health are entitled to:

a) Give warning;

b) Impose a fine of up to 15,000,000 VND for every violation pertaining to population; up to 25,000,000 VND for every violation pertaining to defensive medicine, HIV/AIDS prevention; up to 37,500,000 VND for every violation pertaining to health insurance; up to 50,000,000 VND for every violation pertaining to medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment;

c) Suspend the practising certificate or license, or suspend the operation;

d) Confiscate illegal items the value of which does not exceed the rate of fine mentioned in Point b of this Clause;

dd) Take the remedial measures mentioned in Article 3 of this Article.

3. Chief inspectors of Ministries, the Director of the Department of Population and Birth Control, the Director of the Drug administration of Vietnam, the Director of Medical Examination and Treatment Administration, and the Director of Medical Setting Management Administration, the Director of Defensive medicine Administration are entitled to:

a) Give warning;

b) Impose a fine of up to 30,000,000 VND for every violation pertaining to population; up to 50,000,000 VND for every violation pertaining to defensive medicine, HIV/AIDS prevention; up to 75,000,000 VND for every violation pertaining to health insurance; up to 100,000,000 VND for every violation pertaining to medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment;

c) Suspend the practising certificate or license, or suspend the operation;

d) Confiscate illegal items;

dd) Take the remedial measures mentioned in Article 3 of this Article.

4. Chiefs of inspectorates of Ministries are entitled to:

a) Give warning;

b) Impose a fine of up to 21,000,000 VND for every violation pertaining to population; up to 35,000,000 VND for every violation pertaining to defensive medicine, HIV/AIDS prevention; up to 52,500,000 VND for every violation pertaining to health insurance; up to 70,000,000 VND for every violation pertaining to medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment;

c) Suspend the practising certificate or license, or suspend the operation;

d) Confiscate illegal items the value of which does not exceed the rate of fine mentioned in Point b of this Clause;

dd) Take the remedial measures mentioned in Article 3 of this Article.

5. The entitlements of the chiefs of inspectorates of Services of Health and chiefs of inspectorates of other authorities appointed to carry out inspections are similar to those in Clause 2 of this Article.

Article 91. Entitlements of market surveillance officers to impose penalties

1. Market surveillance officers are entitled to:

a) Give warning;

b) Impose a fine of up to 500,000 VND for every violation pertaining to defensive medicine, medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment.

2. Market surveillance team leaders are entitled to:

a) Give warning;

b) Impose a fine of up to 25,000,000 VND for every violation pertaining to defensive medicine, medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment;

c) Confiscate illegal items the value of which does not exceed the rate of fine mentioned in Point b of this Clause;

d) Take the remedial measures mentioned in Points a, dd, e, h, and I Clause 1 Article 28 of the Law on Penalties for administrative violations and the those in Article 3 of this Decree.

3. Directors of Sub-departments of Market Surveillance affiliated to Services of Industry and Trade, chiefs of Anti-smuggling Department, Anti-counterfeits Department, and Goods Quality Control Department affiliated to Market Surveillance Agency are entitled to:

a) Give warning;

b) Impose a fine of up to 50,000,000 VND for every violation pertaining to defensive medicine, medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment;

c) Confiscate illegal items the value of which does not exceed the rate of fine mentioned in Point b of this Clause;

d) Suspend the practising certificate or license, or suspend the operation;

dd) Take the remedial measures mentioned in Article 3 of this Article.

4. The Director of Market Surveillance Agency is entitled to:

a) Give warning;

b) Impose a fine of up to 25,000,000 VND for every violation pertaining to defensive medicine; up to 100,000,000 VND for every violation pertaining to medical examination, medical treatment, pharmaceuticals, cosmetics, and medical equipment;

c) Confiscate illegal items;

d) Suspend the practising certificate or license, or suspend the operation;

dd) Take the remedial measures mentioned in Article 3 of this Article.

Article 92. Entitlements of police officers to impose penalties

1. Police officers on duty are entitled to:

a) Give warning;

b) Impose a fine of up to 300,000 VND for every violation pertaining to population; up to 500,000 VND for every violation pertaining to prevention of harmful effects of tobacco.

2. The officers senior to the persons mentioned in Clause 1 of this Article are entitled to:

a) Give warning;

b) Impose a fine of up to 900,000 VND for every violation pertaining to population; up to 1.500,000 VND for every violation pertaining to prevention of harmful effects of tobacco.

3. Chiefs of police departments of communes are entitled to:

a) Give warning;

b) Impose a fine of up to 1,500,000 VND for every violation pertaining to population; up to 2.500,000 VND for every violation pertaining to prevention of harmful effects of tobacco.

c) Confiscate illegal items the value of which does not exceed the rate of fine mentioned in Point b of this Clause;

d) Take the remedial measures mentioned in Point a, Point c, and Point dd Clause 1 Article 28 of the Law on Penalties for administrative violations.

4. Chiefs of police departments of districts, chiefs of police divisions in charge of social orders, chiefs of police divisions in charge of investigation into corruption financial crimes are entitled to:

a) Give warning;

b) Impose a fine of up to 6,000,000 VND for every violation pertaining to population; up to 10,000,000 VND for every violation pertaining to prevention of harmful effects of tobacco;

c) Suspend the practising certificate or license, or suspend the operation;

d) Confiscate illegal items the value of which does not exceed the rate of fine mentioned in Point b of this Clause;

dd) Take the remedial measures mentioned in Points, a, c, dd Clause 1 Article 28 of the Law on Penalties for administrative violations and the those in Article 3 of this Decree.

5. Chiefs of police departments of provinces are entitled to:

a) Give warning;

b) Impose a fine of up to 15,000,000 VND for every violation pertaining to population; up to 25,000,000 VND for every violation pertaining to prevention of harmful effects of tobacco;

c) Suspend the practising certificate or license, or suspend the operation;

d) Confiscate illegal items the value of which does not exceed the rate of fine mentioned in Point b of this Clause;

dd) Take the remedial measures mentioned in Points, a, c, dd and i Clause 1 Article 28 of the Law on Penalties for administrative violations and the those in Article 3 of this Decree.

e) Expel foreign offenders in accordance with the laws on expulsion.

6. Chiefs of the police department in charge of social orders and the police department in charge of investigation into corruption and financial crimes are entitled to:

a) Give warning;

b) Impose a fine of up to 30,000,000 VND for every violation pertaining to population; up to 50,000,000 VND for every violation pertaining to prevention of harmful effects of tobacco;

c) Suspend the practising certificate or license, or suspend the operation;

d) Confiscate illegal items;

dd) Take the remedial measures mentioned in Points, a, c, dd and i Clause 1 Article 28 of the Law on Penalties for administrative violations and the those in Article 3 of this Decree.

Article 93. Entitlements of other bodies to impose penalties

1. The Border guard, the Coastguard, customs authorities, tax authorities, the Director of Vietnam Chemicals Agency, inspectors of the Ministry of Science and Technology, the Ministry of Labor, War Invalids and Social Affairs, the Ministry of Information and Communications, the Ministry of Natural Resources and Environment, the Ministry of Transport, the Ministry of Finance, and other bodies are entitled to impose penalties for the violations under their management in accordance with the Law on Penalties for administrative violations.

2. The entitlements to impose administrative penalties and take remedial measures shall be determined in accordance with Article 52 of the Law on Penalties for administrative violations.

Article 94. Entitlements to make records on administrative violations

The persons entitled to make records on administrative violations against medical laws include:

1. The person entitled to impose penalties.

2. Officials and civil servants working in health bodies and social insurance who discover administrative violations.

Chapter 4.

IMPLEMENTATION

Article 95. Effect

1. This Decree takes effect on December 31, 2013.

2. The Government's Decree No. 45/2005/ND-CP dated April 06, 2005 on penalties for administrative violations against medical laws; the Government's Decree No. 114/2006/ND-CP dated October 03, 2006 on penalties for administrative violations pertaining to population and children; the Government's Decree No. 69/2011/ND-CP dated August 08, 2011 on penalties for administrative violations pertaining to defensive medicine, medical setting, and HIV/AIDS prevention; the Government's Decree No. 92/2011/ND-CP dated October 17, 2011 on penalties for administrative violations pertaining to health insurance; the Government's Decree No. 93/2011/ND-CP dated October 18, 2011 on penalties for administrative violations pertaining to drugs, cosmetics, and medical equipment; and the Government's Decree No. 96/2011/ND-CP dated October 21, 2011 on penalties for administrative violations pertaining to medical examination and treatment are abolished from the effective date of this Decree.

Article 96. Transitional provision

The administrative violations against medical laws that are committed before the this Circular takes effect and discovered afterwards, the regulations that are more favorable to the offenders shall apply.

Article 97. Responsibility for instructions and implementation

1. The Minister of Health is responsible for providing instructions, organize and inspect the implementation of this Decree.

2. Other Ministers, Heads of ministerial agencies, Heads of Governmental agencies, Presidents of the People’s Committees, and relevant entities are responsible for the implementation of this Decree.

 

 

FOR THE GOVERNMENT
PRIME MINISTER




Nguyen Tan Dung

 


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